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35 Antiretroviral Therapy Trials Near You
Power is an online platform that helps thousands of Antiretroviral Therapy 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 PowerInjectable Cabotegravir for HIV Prevention
Columbus, Ohio
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Not Listed
4570 Participants Needed
Triple Immune Regimen for HIV
Columbus, Ohio
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus ChAdOx1- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the toll-like receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Autoimmune Disease, Anaphylaxis, Others
Must Be Taking:Integrase Inhibitors, NRTIs
45 Participants Needed
VRC07-523LS + PGT121.414.LS for HIV
Columbus, Ohio
The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:AIDS, Malignancy, ASCVD, Others
Must Be Taking:Protease Inhibitors, Integrase Inhibitors
40 Participants Needed
TXTXT Intervention for HIV Adherence
Cincinnati, Ohio
This trial tests if sending text message reminders can help young people with HIV stick to their medication and keep the virus levels low. The study focuses on youth and young adults who often forget to take their medicine. The text messages serve as reminders to help them stay on track with their treatment.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:16 - 35
Key Eligibility Criteria
Disqualifiers:Age, Informed Consent, Other Study, Others
Must Be Taking:ART
600 Participants Needed
Oral vs Injectable Therapy for HIV
Southfield, Michigan
This trial is testing two treatments for people with HIV-1 who haven't had previous treatments. Participants start with a pill to manage the virus and may later switch to an injection. The study aims to see how well these treatments work and how patients feel about them.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiovascular Disease, Hepatitis B, Others
Must Not Be Taking:Anticoagulants, Immunomodulators, Torsade Drugs
171 Participants Needed
Cabotegravir + Rilpivirine for HIV Infection
Chicago, Illinois
This trial tests new HIV medications in pill and injection forms for children and teens. The medications work by stopping the virus from growing.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Tuberculosis, Hepatitis, Others
Must Be Taking:Antiretrovirals
168 Participants Needed
Estradiol + Biktarvy for Trans Women Living with HIV
Toronto, Ontario
This trial investigates whether common hormone treatments for transgender women interfere with a specific HIV medication. It focuses on transgender women with HIV who are concerned about drug interactions. The study will measure drug and hormone levels in the blood to see if they affect each other.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
45 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
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
Social Network Support for HIV Care
Milwaukee, Wisconsin
The intervention study will recruit 100 out-of-care HIV+ men who have sex with men in online and in community settings located throughout St. Petersburg, Russia. After completing baseline assessments, participants will be randomized to either an individual care counseling (ICC) comparison condition or ICC plus a social support mobilization (SSM) intervention. In each intervention, participants will attend five main and two booster sessions that underscore the benefits of medical care engagement, counter the effects of internalized intersectional stigma and promote resilience, and help participants develop and mobilize social resources supportive of HIV care. Support mobilization will begin by assisting participants develop care-supportive bonds with other group members, friends who are also living with HIV, and connections made with LGBT and other non-governmental organizations. They will also be guided in developing and expanding supportive links with affirmative friends, family members, and other resources. In this way, the intervention will bolster care-related social support resources, resilience, and feelings of self-worth. Assessments administered at baseline will be repeated 6 and 12 months post-intervention, and in-depth followup interviews will be conducted with a subset of 20 participants to elicit feedback about the intervention experience. The study will investigate whether the SSM intervention will produce greater preliminary evidence of benefit on the primary outcome of medical care attendance in the past 6 months and on secondary outcomes of having undetectable viral load, ART adherence, and psychosocial well-being.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:HIV-negative, Adherent To ART, Others
100 Participants Needed
Trauma-Informed Toolkit for HIV Prevention in African American Women
Baltimore, Maryland
Pre-exposure prophylaxis may be a viable option for African American women at-risk for HIV infection, but few studies have identified optimal strategies to reach African American women in need of Pre-Exposure Prophylaxis nor examined effective strategies to scale-up Pre-Exposure Prophylaxis among African American women in the South. African American women in the South experience high rates of intimate partner violence which could force women to choose between HIV prevention or intimate partner violence prevention. The proposed research study seeks to develop, pilot-test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit within two community healthcare clinics located in Jackson, Mississippi to increase Pre-Exposure Prophylaxis uptake among African American, address intimate partner violence as a barrier to Pre-Exposure Prophylaxis uptake, and ultimately combat racial disparities in women's HIV diagnoses.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speaking, Others
30 Participants Needed
Point-of-Care Tests for HIV Diagnosis
Baltimore, Maryland
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S. Current, Standard-of-Care (SOC) diagnostic techniques have extended turn-around-times (TATs) that result in loss of patients to follow up due to delays in laboratory procedures. In this scenario, patients that are at a high-risk for HIV have the potential to continue transmission, making it difficult to end the epidemic. Rapid, Point-of-Care (POC) HIV viral load (VL) testing alleviates this problem by reducing TATs that allow providers to test for HIV infection and link patients to antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) during the same clinical visit, and subsequently, suppress VL, prevent HIV infection, and reduce its transmission among high-risk populations. The study proposes that evaluating the performance of new and existing POC technologies is needed to provide updated information to HIV test providers operating in different populations and settings and improve linkage to HIV treatment and prevention services. The study hypothesizes that:
A. Determining the performance characteristics of HIV POC tests will inform optimal testing strategies in different populations and settings
B. The use of HIV RNA POC tests will improve linkage to HIV treatment and prevention services:
i. Improve early diagnosis of HIV ii. Reduce the time to ART initiation iii. Facilitate timely and appropriate referral for prevention services
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Unwilling, Others
408 Participants Needed
Doravirine for HIV in Pregnancy
Chapel Hill, North Carolina
The purpose of this research study is to evaluate the effect of body changes in pregnancy on doravirine concentrations, to determine what dose of doravirine should be used. Study participants will remain on their normal antiretroviral medications (ARVs) while participating in this study as prescribed by their regular clinic provider. Study participants will come to the research clinic for three sampling visits throughout their time as a participant. Study participants will only take one dose of doravirine during each sampling visit, which will occur during the 2nd and 3rd trimesters, as well as after their baby is delivered. This study was designed intentionally to not give a dose of doravirine in the first trimester when there is the greatest chance for all drugs to potentially cause injury to the baby. Study participants that choose to participate in this study may be enrolled for up to 10 months depending on the length of their pregnancy and how the visits are scheduled.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestation, Hepatitis C, Others
Must Be Taking:Antiretrovirals
10 Participants Needed
Integrated Strategy for PrEP Uptake in HIV Prevention
Durham, North Carolina
HPTN 096 is a community-randomized, controlled, hybrid-type III implementation effectiveness study. It is designed to evaluate an integrated strategy approach to increase the uptake and use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black MSM in the southern United States. A status-neutral approach will be taken such that Black MSM, regardless of HIV status (both those living with and without HIV), will be included in the study.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:15+
Key Eligibility Criteria
Disqualifiers:Not Listed
4800 Participants Needed
Economic Empowerment for HIV Treatment Adherence
Saint Louis, Missouri
The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:10 - 16
Key Eligibility Criteria
Disqualifiers:Not HIV-positive, Others
Must Be Taking:Antiretroviral Therapy
702 Participants Needed
Medications for Opioid Use Disorder in HIV
Philadelphia, Pennsylvania
HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medication for opiate use disorder (i.e, methadone, buprenorphine/naloxone, or extended-release naltrexone) on the kinetics and extent of immune reconstitution on HIV-1 infected people who inject opiate and initiating antiretroviral therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Schizophrenia, Bipolar, Others
Must Be Taking:Methadone, Buprenorphine/naloxone, Naltrexone
225 Participants Needed
HB-502 + HB-501 for HIV
Philadelphia, Pennsylvania
This is a study of HB-502 and HB-501 alternating 2-vector therapy in people living with human immunodeficiency virus (HIV) who are taking antiretroviral treatment (ART).
The benefits of available ART are short-lived and eventually there is a return of rapid HIV replication and higher viral copy number after a period of initial improvement of infection. The study treatment made of HB-502 and HB-501 is designed to train the body to recognize and fight parts from substances found in HIV.
This trial studies the safety, tolerability, and ability of HB-502 and HB-501 to stimulate an immune response against HIV in people living with HIV.
Participants will receive the study treatment by injection into the muscle every 8 weeks for a duration of 24 weeks, which is followed by another 24 weeks to continue looking closely at the safety profile and anti-HIV immune reaction after the last dose of study treatment.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:HIV Malignancy, Neurocognitive Disease, Hepatitis, Others
Must Be Taking:Antiretrovirals
30 Participants Needed
PrEP for HIV Infection
New York, New York
(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence measured by urine assay of Tenofovir (TDF) and longer-term adherence by self-report/medical records over the 12-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.
(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Psychiatric Impairment, Others
300 Participants Needed
WiseApp for HIV
New York, New York
This study aims to conduct a 12-month randomized controlled trial to adapt the mobile app, WiseApp, and a smart pill dispenser for Spanish-speaking people living with HIV (PLWH) in the New York City (NYC) area and La Romana, Dominican Republic (DR). The study will assess the efficacy and sustainability of WiseApp as well as identify barriers with its widespread use among Spanish speakers. With disproportionately high rates of HIV in the New York City area and the Dominican Republic, this project seeks to identify distinct contextual factors related to Spanish speaking people living with HIV and increase the likelihood of engagement with technology and improvements in clinical outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Nursing Home, Terminal Illness, Others
248 Participants Needed
Synthetic DNA + Protein Boosts Vaccine for HIV Protection
Birmingham, Alabama
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with a recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will be safe and immunogenic.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Pregnancy, Morbid Obesity, Diabetes, Others
Must Be Taking:HIV PrEP
46 Participants Needed
Why Other Patients Applied
"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
"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
"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
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"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
SV2A & TSPO PET Imaging for HIV Neurocognitive Disorders
New Haven, Connecticut
The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers \[11C\]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET \[11C\]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Substance Dependence, Neurological Illness, Others
Must Be Taking:Antiretrovirals
70 Participants Needed
MARVIN Chatbots for Breast Cancer
Montréal, Quebec
This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:14+
Key Eligibility Criteria
Disqualifiers:Cognitive Deficit, Others
400 Participants Needed
Early Antiretroviral Therapy for Infant HIV/AIDS
Cambridge, Massachusetts
The overall objective of this study is to determine whether very early antiretroviral treatment (ART) initiation in HIV-infected infants limits the seeding of viral reservoirs and maintains immune responses, potentially allowing future periods off ART.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Age:0 - 3
Key Eligibility Criteria
Disqualifiers:Life-threatening Illness, Survival Unlikely, Others
Must Be Taking:Antiretrovirals
67 Participants Needed
Long-Acting Cabotegravir + rHuPH20 for HIV Infection
Orlando, Florida
This trial is testing a long-lasting HIV medication called Cabotegravir, given as an injection. It also tests if adding rHuPH20 helps the medication spread better in the body. The study focuses on people who need long-term HIV treatment. Cabotegravir is the first long-acting injectable treatment option approved for adults with HIV-1.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Liver Disease, HIV, Others
Must Not Be Taking:Anticoagulants, Drugs Of Abuse
180 Participants Needed
PrEP Awareness Program for HIV Prevention in Black Women
New Orleans, Louisiana
The study objectives are to:
* Evaluate implementation outcomes from piloting the Start the Conversation Initiative
* Assess initial indicators of clinical effectiveness among patients engaged in the Start the Conversation Initiative
These outcomes will be assessed qualitatively through in-depth interviews (IDIs), debriefing sessions with GYN residents and leadership, medical chart reviews and/or de-identified Epic queries, training records, discussions with the Black Women and PrEP (BWAP) Task Force, and social media metrics.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-Black, Non-cisgender, Others
Must Be Taking:PrEP
56 Participants Needed
Doravirine for HIV
Dallas, Texas
This trial is testing doravirine, an HIV medication, in people with HIV who have abnormal cholesterol levels. The goal is to see if doravirine can help control HIV and improve cholesterol and heart health. Doravirine is a newly-approved antiretroviral.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Sex:Male
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hepatitis, Renal Impairment, Others
Must Be Taking:Antiretrovirals
30 Participants Needed
The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Major Depression, Anxiety, Alcohol Use Disorder, Others
Must Not Be Taking:Opioids
45 Participants Needed
mHealth + e-Navigator for Medication Adherence
Miami, Florida
The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:
Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Non-Latino, Female, Under 18, Others
Must Be Taking:ART
250 Participants Needed
DOVATO for HIV
Regina, Saskatchewan
The goal of this clinical trial is to determine the efficacy of Dolutegravir/Lamivudine (DTG/3TC), or "Dovato", in virally-suppressed (HIV-1 RNA \< 200 copies/mL) individuals receiving opioid agonist therapy such as methadone, buprenorphine, slow-release morphine, after switching from their current suppressive antiretroviral therapy (ART).
The main questions this trial seeks to answer are:
1. whether people living with HIV-1 (PLWH) on opioid agonist therapy (OAT) remain virally suppressed after switching to DTG/3TC from their current suppressive ART 48 weeks post-switch;
2. the number and type of adverse events (AEs) and serious adverse events (SAEs) attributable to DTG/3TC as documented per standard process at each study visit, and any discontinuations of DTG/3TC due to AEs and SAEs as determined by the study investigator;
3. the number of dosing changes in OAT attributable to DTG/3TC as determined by the study investigator and documented as per standard progress at each study visit;
4. the number of persons with any recreational or non-prescribed substances in their urine drug screens who remain virally suppressed (HIV-1 RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC;
5. any change from baseline values (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC of serum creatinine and non-fasting lipid parameters;
6. any change from baseline value (i.e., day 0) to 48 weeks post-switch from current suppressive ART to DTG/3TC in HIV Treatment Satisfaction Questionnaire (Status) (HIVTSQs) scores;
7. the number of persons who remain virally suppressed (HIV RNA \< 200 copies/mL) at 48 weeks post-switch from current suppressive ART to DTG/3TC in conjunction with differing levels of adherence to DTG/3TC, and;
8. the number of persons who experience symptoms of opioid withdrawal or overdose per standardized survey or by self-report (e.g., overdose events)
During the course of the study, participants will complete:
* A set of questionnaires
* Blood draws
* A review of adverse events and concomitant medications
* ECG scans at screening and 48 weeks
* Urine drug screening
* Physical exams
* Review of alcohol consumption
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Hepatitis B, Tuberculosis, Pregnancy, Others
Must Be Taking:Opioid Agonist Therapy
40 Participants Needed
Team-Based Care for HIV
Loma Linda, California
Exploring the effect of team-based ARTAS intervention in an inpatient setting on HIV linkage to care and hospital readmission rates.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Virally Suppressed, Under HIV Care, Others
Must Not Be Taking:ART
250 Participants Needed
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Frequently Asked Questions
How much do Antiretroviral Therapy 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 Antiretroviral Therapy 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 Antiretroviral Therapy 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 Antiretroviral Therapy 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 Antiretroviral Therapy 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 Antiretroviral Therapy clinical trials?
Most recently, we added VRC07-523LS + PGT121.414.LS for HIV, PrEP for HIV Infection and DOVATO for HIV to the Power online platform.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.