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113 Aids Trials Near You
Power is an online platform that helps thousands of Aids patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerCBT + HIV Risk Reduction for Social Anxiety
Toronto, Ontario
Given the continued high human immunodeficiency virus (HIV) prevalence rates among gay, bisexual, and other men who have sex with men (MSM) in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal and performance situations, is a reliable risk factor for condomless anal sex (CAS) among MSM. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide the first efficacy data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and therapies to reduce social anxiety. The investigators propose to test the efficacy of a novel integrated HIV prevention intervention that combines the most empirically supported treatment for social anxiety disorder, cognitive-behavioural therapy, with HIV risk reduction counselling in order to simultaneously treat social anxiety disorder, substance use disorders, and HIV sexual risk behaviour. This study will be a randomized controlled trial comparing the study intervention relative to applied relaxation, a behavioural intervention that is efficacious in treating social anxiety disorder but that does not address substance use problems or HIV sexual risk behaviours. For this trial, 176 participants will be randomized to either 12 sessions of cognitive-behavioural therapy with HIV risk reduction counselling or 12 sessions of applied relaxation.
Participants will be eligible for the trial if they are HIV-negative, report clinically significant symptoms of social anxiety disorder, substance use 2 hours before or during sexual activity, and CAS without the use of pre-exposure prophylaxis (PrEP) with a male partner who was not known to be HIV-negative. PrEP is a biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV.126 The present intervention, if found to be efficacious, is innovative in that mental health clinicians will be able to not only extend empirically supported therapies tested primarily with heterosexual populations to MSM, but they will also be able to prevent HIV through empirically supported psychotherapy practice.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:PrEP, Disabilities, Non-English Speakers, Others
Must Not Be Taking:PrEP
176 Participants Needed
Patient Decision Aid for Antidepressant Use During Pregnancy
Toronto, Ontario
Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created and piloted with positive results an online patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this study is to conduct a Randomized Controlled Trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy.
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
574 Participants Needed
Genetics Navigator for Genetic Conditions
Toronto, Ontario
Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results. We have previously developed and tested an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) to be used for genetic testing decision making, and have now developed the Genetics Navigator (GN), a patient-centred e-health navigation platform for end-to-end genetic service delivery. The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered genetic testing. Results of this trial will be used to establish whether the GN is effective to use in practice. If effective, GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse of services. These are concerns policy makers seek to address through the triple aims of health care1. This study represents a significant advance in personalized health by assessing the effectiveness of this novel, comprehensive e-health platform to ultimately improve genetic service delivery, accessibility, patient experiences, and patient outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ineligible For Testing, Urgent Testing, Non-English Speakers
170 Participants Needed
UB-421 for Multi-Drug Resistant HIV
Bethesda, Maryland
Background:
People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated. Untreated HIV infection can make people more vulnerable to other infections as well as some cancers. Better treatments are needed for people with drug-resistant HIV.
Objective:
To see if a study drug (UB-421) is effective in people with drug-resistant HIV.
Eligibility:
People aged 18 years and older with HIV that is resistant to anti-HIV drugs.
Design:
Participants will be in the study for 35 weeks.
Participants will have separate screening and baseline visits within 2 months of each other. They will have a physical exam with blood and urine tests both times. On the second visit, they will undergo apheresis: Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
Participants will begin receiving the study drug 1 week after their baseline visit. UB-421 is given through a tube attached to a needle placed in a vein in the arm. They will return for UB-421 treatments every week for 26 weeks. Each visit will take 3 to 6 hours.
Participants will have 2 follow-up visits 4 and 8 weeks after their last treatment with UB-421. Apheresis will be repeated at 1 of these visits.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Hepatitis B, Hepatitis C, AIDS, Others
Must Be Taking:Antiretrovirals
25 Participants Needed
Background:
People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.
Objective:
This study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.
Eligibility:
People aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.
Design:
The study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.
Participants will be screened. Their diagnoses, organ function and eligibility will be confirmed.
Participants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.
Participants will be in the hospital for 6 weeks or longer.
They will receive various drugs for 2 weeks to prep their body for the transplant.
The transplant cells will be administered through the catheter.
Participants will continue to receive drug treatments after the transplant.
Blood transfusions may also be needed.
Participants will return 1-2 times per week for follow-up visits for 3 months after discharge.
Participants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Illness, Active Psychiatric Disorder, Others
Must Be Taking:Antiretrovirals
265 Participants Needed
Imaging and Biopsy During Treatment Interruption for HIV/AIDS
Bethesda, Maryland
This trial uses special scans and tissue samples to find and study areas in the body where HIV might still be active in adults receiving ongoing HIV treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Hepatitis, Others
Must Be Taking:Antiretrovirals
50 Participants Needed
Lenacapavir for HIV
Bethesda, Maryland
Pending...
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:AIDS, Hepatitis B/C, Pregnancy, Others
Must Be Taking:ART
50 Participants Needed
Antibody Treatment for HIV
Bethesda, Maryland
Background:
HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immunodeficiency syndrome). Researchers want to find new ways to treat or prevent HIV infection. CAP256J3LS is a new product that uses antibodies. Antibodies are naturally occurring proteins; they target and disable disease-causing agents such as viruses. This new product may be able to stop HIV infections.
Objective:
To test the safety of CAP256J3LS in healthy people.
Eligibility:
People aged 18 to 60 years in good general health.
Design:
CAP256J3LS can be administered in 2 ways: (1) by a shot under the skin into the belly fat or (2) through a tube inserted into a vein in the arm. Participants will be divided into 6 groups: The study will open with the lowest dose of study product. The dose groups are spaced out to allow the study team to look over the safety data in each group. If there are no safety concerns in the lowest dose, then the next higher dose groups will be enrolled. This pattern will continue until all dose groups are enrolled.. Also, some participants will receive only 1 dose; others will receive 3 doses, each spaced 12 weeks apart.
Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months. Those who get 3 doses will have 27 visits over 11 months. Participants will provide blood samples at each visit. Urine samples may also be needed.
All participants will get a thermometer and a measuring tool. They will measure any redness, swelling, or bruising they have at the injection site. They will check their temperature every day for 7 days after receiving the study drug. They will record their highest temperatures and any symptoms they have.
...
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypertension, Diabetes, Others
Must Not Be Taking:Immunosuppressants, Cytotoxics, Others
24 Participants Needed
Self-Test for HIV and Syphilis
Toronto, Ontario
To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Laboratories Inc. (Halifax, Nova Scotia, Canada) has developed a point-of-care (POC) test to detect HIV and Syphilis antibodies in fingerstick blood samples that is under final review by Health Canada for use by trained Healthcare professionals. A self-test version of this test, with simplified instructions for use has been developed for investigational studies. The goal of the following study sponsored by REACH Nexus is to provide evidence that untrained lay persons / intended users can perform the Multiplo Tp/HIV Self-Test without any increased risk of obtaining erroneous results.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:HIV Positive, Syphilis Positive, Healthcare Professional, Others
900 Participants Needed
Transitional Care Program for HIV, Hepatitis C, and Substance Use Disorders
Union Grove, Wisconsin
This trial tests a program called CJC-TraC that helps people leaving prison get the medical care they need. It focuses on those with HIV, Hepatitis C, or substance misuse history. The program coordinates their medical care to ensure they continue treatment after release. New treatments have made it easier and faster to cure Hepatitis C.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Listed
219 Participants Needed
Virotherapy for Castleman Disease
Bethesda, Maryland
This study will gain information about a rare disorder called KSHV-associated multicentric Castleman s disease (MCD). KSHV, a virus, causes several kinds of cancer, including some forms of MCD. KSHV stands for the Kaposi s sarcoma herpes virus, also called human herpes virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how this disease causes illness and to find ways to treat it. There is no standard therapy effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people who have it die within 2 years of diagnosis.
Participants ages 18 and older may be eligible for this study. Participation entails more drawing of blood and having repeated tumor biopsies than if patients received treatment in a non-research setting. Researchers would like to learn more about the relationship of KSHV and Castleman s disease symptoms, and they want to obtain at least three biopsies in this study.
There are some side effects of experimental therapy that participants may take for KSHV-MCD. Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow function, leading to low blood counts, sterility, and defects in a fetus. Combined with zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid push through a needle into the vein. It is given twice weekly for four doses and then stopped for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the skin. Those drugs are not experimental, but their use in Castleman s disease is experimental.
Some participants may be treated with a combination of chemotherapy followed by interferon-alpha. Interferon-alpha is infected into the skin by a needle. The natural form of interferon is produced by the body and helps to control viral infections. KSHV decreases the effect of the body s interferon, and the researchers want to see if giving higher doses of interferon will help to control KSHV infection.
A positron emission tomography (PET) scan, for research purposes only, may be done up to three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used. It is believed that activated lymphocytes that may be found in participants disease might use more FDG because these cells burn more glucose fuel.
This study may or may not have a direct benefit for participants. However, detailed assessments made throughout the study may provide information to help the doctors treat KSHV-MCD better.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Other Malignancy, Grade IV Toxicity, Others
75 Participants Needed
Gene Therapy + Chemotherapy for AIDS-Related Lymphoma
Bethesda, Maryland
This pilot clinical trial studies gene therapy following combination chemotherapy in treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma. Placing genes that have been shown in the laboratory to inhibit the growth and spread of the immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the body's ability to fight HIV. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gene therapy after combination chemotherapy may improve the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Opportunistic Infections, CMV Retinitis, Others
Must Be Taking:Antiretrovirals
10 Participants Needed
Chemotherapy + Pomalidomide for HIV-Associated Lymphoma
Bethesda, Maryland
This trial tests a combination of pomalidomide and chemotherapy, with or without rituximab, in adults with HIV and high-risk B-cell non-Hodgkin lymphoma. Pomalidomide boosts the immune system and helps increase important immune cells. The goal is to find the safest and most effective dose for this treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Brain Involvement, Heart Failure, Others
Must Be Taking:ART, Antivirals
25 Participants Needed
Pomalidomide + Liposomal Doxorubicin for Kaposi Sarcoma
Bethesda, Maryland
Background:
Kaposi sarcoma (KS) is a cancer most often seen in people with HIV. It causes lesions. These are usually on the skin but sometimes in the lymph nodes, lungs, and gastrointestinal tract. Researchers think a combination of drugs may help treat KS.
Objective:
To test a combination of the anti-cancer drugs pomalidomide (CC-4047) and liposomal doxorubicin (Doxil) in people with KS.
Eligibility:
People ages 18 and over with KS
Design:
Participants will be screened with:
Medical history
Questionnaires
Physical exam
Blood, urine, and heart tests
Chest X-ray
Biopsy: A small sample of tissue is taken from a KS lesion.
Possible CT scan
Possible exam of lungs or gastrointestinal tract with an endoscope: A flexible instrument examines
inside the organ.
Participants will take the drugs in 4-week cycles. They will take Doxil through an IV on Day 1 of each cycle. They will take CC-4047 tablets by mouth each day for the first 3 weeks of each cycle.
Participants will have many visits:
Before starting treatment
To start each cycle
Day 15 of first 2 cycles
Visits include repeats of screening tests and:
Multiple blood draws
Photographs of lesions
Participants will keep a drug diary.
Participants will take aspirin or other drugs to prevent blood clots.
Participants with HIV will have combination antiretroviral therapy.
Some participants will have a PET scan.
Participants will continue treatment as long as they tolerate it and their KS improves. After treatment, they will have several follow-up visits for up to 5 years
...
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Primary Effusion Lymphoma, Uncontrolled Illness, Others
Must Be Taking:Antiretrovirals, Aspirin
62 Participants Needed
Lenalidomide + EPOCH-R for Lymphoma
Bethesda, Maryland
Background:
Primary effusion lymphoma (PEL) is a rare disease with no standard treatment. Researchers want to see if a drug called lenalidomide along with common chemotherapy drugs may be effective in treating PEL.
Objective:
To test a new treatment for PEL.
Eligibility:
People ages 18 and older with PEL.
Design:
Participants will be screened with blood tests, imaging studies, a physical exam, and other tests.
Participants will have tests to evaluate their disease. These may include:
Blood tests
Scans
Lumbar puncture. Fluid around the spinal cord will be removed with a needle.
Bone marrow removed with a needle and studied
Samples of skin or lymph nodes removed
Fluid removed from around organs
Lung and eye tests
Tubes with cameras taking pictures of airways or digestive tract
Participants will take lenalidomide pills for 10 days. They will keep a pill diary.
Participants will have a catheter (small tube) placed in the large vein in the arm or chest.
Participants will get DA-EPOCH-R as intravenous infusions by catheter over several days. This will be repeated in 21-day cycles. Most participants will have 6 cycles.
Participants will get the drug filgrastim by injection under the skin. They will get the drug methotrexate injected into the spinal fluid.
During the study, participants will have the following tests done at least once:
Medical history
Physical exam
Blood, urine, and stool tests
Lesions photographed and measured
Lumbar puncture
Participants will have follow-up visits for 5 years. They will repeat the screening tests plus have urine and stool tested.
Participants may be contacted later by phone to see how they are doing.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Brain Involvement, Renal Dysfunction, Hepatic Dysfunction, Others
Must Be Taking:Lenalidomide, DA-EPOCH-R
17 Participants Needed
Decision Aid for Thyroid Cancer
Falls Church, Virginia
The goal of this study is to learn if a decision aid (DA) website helps people with thyroid cancer make informed decisions about radioactive iodine (RAI) treatment. The main questions it aims to answer are: - Does the decision aid help participants understand the risks and benefits of RAI treatment? - Does it help participants make choices that reflect what matters most to them? - How does the decision aid compare to usual care in supporting patients through this decision? Participants who have been recently diagnosed with intermediate-risk differentiated thyroid cancer (DTC) will be randomly assigned to one of two groups. One group will receive a special decision aid website. This site includes detailed information about RAI, short videos, drop-down menus with extra details, exercises to help clarify values, and tools to help patients prepare questions for their doctor. The other group will receive the American Cancer Society (ACS) website. This site gives basic information about RAI but does not include interactive tools and is not specific to intermediate-risk thyroid cancer. Follow up surveys will be sent to the participants periodically, first at the start of the study, and again at 1 week, 4 weeks, and 6 months later.
Researchers will compare how the two groups differ in making informed decisions. The decision aid is meant to support, not replace, a conversation with the medical team. Doctor recommendations remain an important part of treatment decisions.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Low/high Risk DTC, Prior RAI, Others
408 Participants Needed
NHS-IL12 + M7824 for Kaposi Sarcoma
Bethesda, Maryland
Background:
Kaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal tract. KS often affects people with immune deficiencies, such as among people living with HIV or those with prior history of transplant. Researchers want to see if 2 non-chemotherapy drugs can help people with KS. NHS-IL12 triggers the immune system to fight tumors. M7824 blocks the pathways that cancer cells use to stop the immune system from fighting tumors.
Objective:
To learn if giving NHS-IL12 alone or with M7824 could help the immune system fight KS tumors.
Eligibility:
People 18 and older with KS that has been treated with chemotherapy or immunotherapy
Design:
Participants will be screened with some or all of the following:
medical history
physical exam
chest X-ray
computed tomography scan
blood and urine tests
electrocardiogram and echocardiogram
skin KS lesion biopsy
lung exam
gastrointestinal exam
All participants will get NHS-IL12 every 4 weeks for up to 96 weeks (or 24cycles). It is injected under the skin.
Some participants will also get M7824 every 2 weeks for up to 96 weeks (or 24cycles). It is given through a plastic tube that is put in an arm vein.
Participants will complete questionnaires about how KS affects their quality of life. Their KS lesions will be measured and photographed. They will repeat some of the screening tests. They will give saliva samples or additional tissue samples. They will have a lung function test. Their ability to perform their normal activities will be assessed. The treatment duration is up to 96 weeks (or 24cycles) with an option to take NHS-IL12 and/or M7824 until the KS tumors are not responding, or you develop unacceptable side effects.
Participants will have follow-up visits 7 and 30 days after treatment ends, then every 3 to 6 months for the next 18 months, then once a year for 3 years.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Severe KS, Autoimmune Disease, Others
Must Be Taking:ART
80 Participants Needed
Abemaciclib for Kaposi Sarcoma
Bethesda, Maryland
Background:
Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help.
Objective:
To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors.
Eligibility:
People ages 18 and older with KS.
Design:
Participants will be screened with some or all of the following:
Medical history
Physical exam
Blood and urine tests
Chest x-ray and/or computed tomography scans
Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ)
Medicine review
Heart function tests
KS lesion assessment
Skin sample from a KS lesion
Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects.
Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed.
Participants will have follow-up visits for up to 2 years after treatment ends.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Chemotherapy, Immunotherapy, Pregnancy, Others
Must Be Taking:Antiretrovirals
86 Participants Needed
Pomalidomide + Nivolumab for Viral Associated Cancers
Bethesda, Maryland
Background:
Less toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, anal cancer, cervical cancer, vaginal cancer, vulvar cancer, penile cancer, Merkel cell carcinoma, Kaposi sarcoma, and leiomyosarcoma. Researchers want to see if a combination of drugs can help.
Objective:
To find a safe dose of pomalidomide plus nivolumab in people with cancers caused by viruses.
Eligibility:
Adults ages 18 or older who have cancers caused by Epstein Barr virus (EBV), human herpes virus 8/Kaposi sarcoma herpesvirus (HHV8/KSHV), human papilloma virus (HPV), hepatitis B or C virus (HBV/HCV), and Merkel cell polyomavirus (MCPyV) that have not responded to previous treatments or have relapsed, or in adults who do not want to have surgery because of disfigurement or other risks. Adults who have HIV with any CD4 T cell count are eligible.
Design:
Participants will be screened with blood and urine tests, scans, and heart tests. They will have a physical exam. Their ability to perform normal daily activities will be assessed. They may have a tumor biopsy.
Treatment will be given in 28-day cycles. Participants will take pomalidomide as a tablet by mouth for 21 days of each cycle, for up to 24 cycles. They will get nivolumab by intravenous infusion once each cycle. They will take an aspirin each day until 30 days after their last dose of the study drugs.
Participants will keep a pill diary. They will bring it to their study visit at the end of each cycle. At these visits, some screening tests will be repeated. Participants with Kaposi sarcoma will have pictures taken of their lesions.
Participants will give blood and saliva samples for research. They may have optional anal and/or cervical swabs. They may have optional biopsies.
Participants will have a follow-up visit 30 days after they stop taking the study drugs, then every month for 100 days. Some screening tests will be repeated. Then they may by contacted by phone every 3 months for 9 months, and then every 6 months thereafter....
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Illness, Cirrhosis, Others
Must Be Taking:Antiretrovirals, Aspirin
58 Participants Needed
HIV Vaccine + ALFQ for HIV Prevention
Silver Spring, Maryland
This trial is testing a new vaccine with components A244 and B.63521, plus an immune-boosting substance called ALFQ. ALFQ helps enhance immune responses. The vaccine is for healthy adults without HIV to ensure safety and effectiveness. The vaccine trains the immune system to fight infections, and ALFQ enhances this training.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Cancer, Autoimmune Disease, Diabetes, Others
Must Not Be Taking:Immunosuppressants, Cytotoxics, Immunomodulators, Others
60 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
PositiveLinks mHealth Platform for HIV/AIDS
Washington, District of Columbia
To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16+
Key Eligibility Criteria
Disqualifiers:Age Below 16, Others
753 Participants Needed
Peer-Led Intervention for HIV Postpartum Care
Washington, District of Columbia
The purpose of this study is to test the efficacy of a theory-driven peer intervention for pregnant and postpartum women living HIV. The peer intervention is designed to increase self-efficacy, social support, self-regulatory behaviors, and outcome expectancy in order to improve retention in care and viral suppression postpartum. The intervention will consist of face-to-face prenatal educational sessions, starting in early third trimester, and postpartum sessions scheduled up to three months postpartum.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:16+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Relocating Outside Country
151 Participants Needed
HIV Medications for Children With HIV
Washington, District of Columbia
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:4 - 17
Key Eligibility Criteria
Disqualifiers:Drug Resistance, Inadequate Renal Function, Others
Must Be Taking:Antiretrovirals
133 Participants Needed
Proactive E-consults for COPD in HIV/AIDS Patients
Washington, D.C., District of Columbia
This study examines an intervention to promote effective, evidence-based care and de-implement inappropriate therapies for COPD in HIV-infected (HIV+) patients. The intervention facilitates specialist support of primary care, which includes infectious disease (ID) physicians who serve as the primary care providers (PCP) for their HIV+ patients in the ID clinic. Rather than relying on referral-driven specialty care which may be a barrier to access, pulmonologists will proactively support ID providers to manage a population of HIV+ patients with COPD, delivering real-time evidence-based recommendations tailored to the individual HIV+ patient in the form of an E-consult.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Listed
270 Participants Needed
E/C/F/TAF for HIV-1 Infection
Washington, District of Columbia
This trial tests a single pill combining four HIV medications in adolescents and children. It aims to find the right dose and ensure safety for those new to treatment and those already on it. The pill works by stopping the virus from growing and spreading.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Hepatitis B, Hepatitis C, Tuberculosis, Others
Must Be Taking:Antiretrovirals
129 Participants Needed
Gardasil HPV Vaccine for Human Papillomavirus
Washington, District of Columbia
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Sex:Male
Key Eligibility Criteria
Disqualifiers:Born Female, Hypersensitivity, Others
Must Be Taking:Androgen Blockers, Estrogen
120 Participants Needed
Probiotic + Prebiotic for Fatty Liver in HIV/AIDS
Nashville, Tennessee
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Celiac, Hepatitis C, Others
Must Be Taking:Antiretrovirals
63 Participants Needed
HIV Vaccine + Adjuvant for HIV Prevention
Nashville, Tennessee
HVTN 144 is a phase 1 clinical trial to being conducted to evaluate the safety and immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with saponin/MPLA nanoparticles (SMNP) in adult participants without HIV. The study aims to evaluate the safety and tolerability of N332-GT5 gp140 adjuvanted with SMNP in adult volunteers without HIV and in overall good health, including identifying a safe and tolerable dose, route, and schedule of administration of the novel adjuvant SMNP. The study also aims to evaluate the induction of BG18-class immunoglobulin G (IgG) B-cell responses in memory B cells by the study regimens and compare the responses between the different groups.
HVTN 144 will be conducted in 2 parts with 84 volunteers without HIV and in overall good health, aged 18 to 55 years. The study duration is 22 months which includes 8 months for enrollment, planned safety holds, follow-up, and Adverse Event of Special Interest (AESI) health contact 1 year after last vaccination.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Hypertension, Asthma, Others
Must Not Be Taking:Immunosuppressants, Monoclonal Antibodies
57 Participants Needed
Case Management and Peer Support for HIV
Milwaukee, Wisconsin
Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Under 50, Urban Residence, Others
Must Be Taking:Antiretrovirals
352 Participants Needed
HIV Vaccines for HIV/AIDS
Nashville, Tennessee
This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
42 Participants Needed
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Frequently Asked Questions
How much do Aids clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Aids clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Aids trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Aids is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Aids medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Aids clinical trials?
Most recently, we added Peer Navigator Training for HIV Prevention in Hispanic/Latino Men, WISH Program for Cancer Treatment and Pramipexole vs Escitalopram for Depression in HIV to the Power online platform.
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