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95 HIV/AIDS Trials Near You
Power is an online platform that helps thousands of HIV/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 PowerReduced-Dose HPV Vaccine for Women with HIV
Hamilton, Ontario
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally.
This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time.
This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Allergy To Vaccine, Others
450 Participants Needed
Brentuximab Vedotin + Chemotherapy for Hodgkin's Lymphoma
Chicago, Illinois
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, 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 brentuximab vedotin together with combination chemotherapy may kill more cancer cells.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
41 Participants Needed
Health and Employment Services for HIV/AIDS
Chicago, Illinois
The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system.
The main question it aims to answer is:
• Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community?
Participants on the study will be:
* Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group.
* Complete three surveys over the course of 13 months
* Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months
* Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Informed Consent, Location, HIV Status, Others
350 Participants Needed
CAR-T Therapy for B-Cell Lymphoma
Chicago, Illinois
This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, CNS Pathology, Others
Must Be Taking:Antiretrovirals
20 Participants Needed
Chemotherapy + Radiation for HIV-Associated Anal Cancer
Chicago, Illinois
This trial studies the effects of chemotherapy, radiation, and immunotherapy in treating HIV-associated anal cancer. It targets both low-risk and high-risk patients, aiming to kill cancer cells and help the immune system prevent the cancer from coming back.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Live Vaccines, Autoimmune Disease, Others
Must Be Taking:Antiretroviral Therapy
40 Participants Needed
HST-NEETs + Bone Marrow Transplant for Lymphoma
Chicago, Illinois
This is a Phase II multi-center trial single arm trial of autologous transplantation (ASCT) followed by administration of HST-NEETs for treatment of HIV associated lymphoma
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:15+
Key Eligibility Criteria
Disqualifiers:HIV Subtype Other Than B, Others
Must Be Taking:Antiretroviral Therapies
12 Participants Needed
DOR/ISL for HIV/AIDS
Hamilton, Ontario
This trial aims to check if the combination of DOR and ISL is safe and well-tolerated in adults with HIV-1 who have used these drugs before. The study focuses on ensuring that the treatment does not cause harmful side effects in these patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV-1 RNA ≥200 Copies/mL, Others
Must Be Taking:Doravirine/Islatravir
650 Participants Needed
DOR/ISL for HIV/AIDS
Hamilton, Ontario
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
643 Participants Needed
Peer Navigator Training for HIV Prevention in Hispanic/Latino Men
Winston-Salem, North Carolina
There is an urgent need to address HIV inequities and disparities in the US, particularly within vulnerable communities such as Hispanic/Latino gay, bisexual, and other men who have sex with men (HLMSM).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Less Than 18, Female
144 Participants Needed
Lifestyle Interventions for Aging with HIV/AIDS
Winston-Salem, North Carolina
The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Under 50, Unable To Complete Assessments
100 Participants Needed
Bilingual Intervention for HIV/AIDS-Related Food Insecurity
Winston-Salem, North Carolina
This trial tests a program to help people with HIV who don't have enough food. It aims to improve their blood sugar levels by ensuring they have enough to eat. The goal is to reduce the risk of diabetes and related health issues.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Others
200 Participants Needed
iEngage Social Network Intervention for HIV/AIDS
Winston-Salem, North Carolina
human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely.
While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries.
This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:15 - 21
Key Eligibility Criteria
Must Be Taking:Antiretrovirals
30 Participants Needed
ARTEMIS + Contingency Management for Depression
Winston-Salem, North Carolina
The purpose of this research is to understand how chronic stress affects the way our brain and immune systems function, and in turn how this affects the way people feel, think, and behave. By learning more about how these processes work, the hope is to be able to develop better treatments to help with problems like depression and substance use. This study is intended for individuals that are HIV positive, currently taking prescription antiretroviral medications, and use stimulants. Through this intervention, the aim is to determine if this positive affect intervention can lead to reductions in stimulant use and depressed mood.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 59
Key Eligibility Criteria
Disqualifiers:Acute Brain Infection, Bipolar, Others
Must Be Taking:Antiretrovirals
189 Participants Needed
Peer Navigation + mHealth for HIV/AIDS, STIs, and Hepatitis C Testing
Winston-Salem, North Carolina
By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia.
Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:None
141 Participants Needed
Imiquimod vs. Fluorouracil for Anal Lesions in HIV/AIDS
Winston-Salem, North Carolina
This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade anal squamous skin lesions who are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:21+
Key Eligibility Criteria
Disqualifiers:Not Listed
91 Participants Needed
Chronic Cannabis Use for HIV/AIDS Neuroinflammation
Winston-Salem, North Carolina
This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 59
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Mental Illness, Others
Must Be Taking:CART
220 Participants Needed
CBT + 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
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
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 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
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"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
"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
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
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
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
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
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
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Frequently Asked Questions
How much do HIV/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 HIV/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 HIV/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 HIV/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 HIV/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 HIV/AIDS clinical trials?
Most recently, we added Peer Navigator Training for HIV Prevention in Hispanic/Latino Men, Lenacapavir for HIV and Pre-Exposure Prophylaxis for HIV Prevention to the Power online platform.
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