HIV clinical trials, in English

There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART).

NCT00039689 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.

NCT00451022 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.

NCT00789009 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

NCT03025074 · Official ClinicalTrials.gov record · State University of New York at Buffalo

The goal of this watch-and-measure (no experimental treatment required) study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements. Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year.

NCT04979728 · Official ClinicalTrials.gov record · University of Colorado, Denver

This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.

NCT05418868 · Official ClinicalTrials.gov record · ViiV Healthcare

Background: Human immunodeficiency virus (HIV) infects CD4 T cells. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection.

NCT05419024 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

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.

NCT05470491 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18.

NCT05580458 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial.

NCT05785169 · Official ClinicalTrials.gov record · Columbia University

Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors.

NCT06001814 · Official ClinicalTrials.gov record · Massachusetts General Hospital

Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort.

NCT06004011 · Official ClinicalTrials.gov record · Implenomics

This study wants to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

NCT06310551 · Official ClinicalTrials.gov record · ViiV Healthcare

The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for side effects. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.

NCT06337032 · Official ClinicalTrials.gov record · Gilead Sciences

Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract.

NCT06375122 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This randomly assigned Type 1 hybrid effectiveness-implementation trial (N=186) will measure the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: measure the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To measure the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.

NCT06501781 · Official ClinicalTrials.gov record · University of Maryland, Baltimore

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomly assigned controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1.

NCT06599658 · Official ClinicalTrials.gov record · McGill University Health Centre/Research Institute of the McGill University Health Centre

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and how well it works of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1.

NCT06749054 · Official ClinicalTrials.gov record · Gilead Sciences

For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression.

NCT06799338 · Official ClinicalTrials.gov record · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. HIV can remain in the body, in infected cells called reservoirs.

NCT06819176 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed.

NCT06843902 · Official ClinicalTrials.gov record · Massachusetts General Hospital

The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session.

NCT06868641 · Official ClinicalTrials.gov record · Columbia University

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health.

NCT06880705 · Official ClinicalTrials.gov record · Illinois Institute of Technology

The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP.

NCT06930508 · Official ClinicalTrials.gov record · Women and Infants Hospital of Rhode Island

The goal of this watch-and-measure (no experimental treatment required) study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers.

NCT07021495 · Official ClinicalTrials.gov record · Leiden University Medical Center

LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study.

NCT07065552 · Official ClinicalTrials.gov record · UNC Lineberger Comprehensive Cancer Center

Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally.

NCT07199634 · Official ClinicalTrials.gov record · Boston University

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

NCT07218211 · Official ClinicalTrials.gov record · Duke University

This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.

NCT07240220 · Official ClinicalTrials.gov record · Indiana University

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body.

NCT07266831 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

PrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.

NCT07335289 · Official ClinicalTrials.gov record · Massachusetts General Hospital

Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its how well it works can be suboptimal in WLWH.

NCT07390916 · Official ClinicalTrials.gov record · Fred Hutchinson Cancer Center

This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings.

NCT07467018 · Official ClinicalTrials.gov record · University of California, Los Angeles

Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its how well it works can be suboptimal in WLWH.

NCT07468695 · Official ClinicalTrials.gov record · Fred Hutchinson Cancer Center

The goal of this clinical trial is to see if receiving chatbot-delivered stage-of-change-tailored online interventions is effective in reducing chemsex among men who have sex with men in Hong Kong. The main question it aims to answer is: Does chatbot-delivered stage-of-changed online interventions reduce chemsex among men who have sex with men Eligible you would be randomly assigned to either the intervention or the control group.

NCT07472582 · Official ClinicalTrials.gov record · Chinese University of Hong Kong

The goal of this watch-and-measure (no experimental treatment required) study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.

NCT07473778 · Official ClinicalTrials.gov record · Gilead Sciences

The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP).

NCT07497594 · Official ClinicalTrials.gov record · Oswaldo Cruz Foundation

People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality.

NCT07507435 · Official ClinicalTrials.gov record · Seattle Institute for Biomedical and Clinical Research

Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women.

NCT07518914 · Official ClinicalTrials.gov record · University of Pennsylvania

This study wants to measure the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD).

NCT07525271 · Official ClinicalTrials.gov record · Yale University

To measure the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to measure the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.

NCT07569913 · Official ClinicalTrials.gov record · bioLytical Laboratories

Background: Human immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell.

NCT07637669 · Official ClinicalTrials.gov record · National Institute on Drug Abuse (NIDA)

Phase IV, multi-site, open-label, non-randomly assigned study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.

NCT07637942 · Official ClinicalTrials.gov record · International Maternal Pediatric Adolescent AIDS Clinical Trials Group

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35.

NCT07645287 · Official ClinicalTrials.gov record · Gilead Sciences

Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its how well it works can be suboptimal in WLWH.

NCT07645352 · Official ClinicalTrials.gov record · Fred Hutchinson Cancer Center

This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time.

NCT07649304 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study compares the how well it works, whether it is safe and how hard side effects are to live with of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

NCT07650916 · Official ClinicalTrials.gov record · ViiV Healthcare

The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

NCT07682961 · Official ClinicalTrials.gov record · Gilead Sciences

The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. The primary objective of this study is to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.

NCT07683000 · Official ClinicalTrials.gov record · Gilead Sciences

Consistent use of antiretroviral therapy (ART) is essential for achieving suppression among people with HIV (PWH). Yet despite improvements in access to ART and improving viral suppression rates, an estimated one-third of PWH globally do not take ART as prescribed, thus allowing the virus to remain detectable and transmissible.

NCT07703891 · Official ClinicalTrials.gov record · University of Pennsylvania

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.

NCT07708727 · Official ClinicalTrials.gov record · Gilead Sciences

This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents.

NCT07708961 · Official ClinicalTrials.gov record · Mayo Clinic

The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are: * Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?

NCT07756736 · Official ClinicalTrials.gov record · Nicky Mehtani, MD, MPH

This Vietnam-based watch-and-measure (no experimental treatment required) study examines ecto-nucleotide pyrophosphatase/phosphodiesterase 1/cyclic GMP-AMP synthase (ENPP1/cGAS) protein and stromal fibroblast activation protein (FAP) expression in multiple solid tumor samples using immunohistochemistry (IHC). The study involves no investigational treatments or participant-facing procedures.

NCT07808164 · Official ClinicalTrials.gov record · Tam Anh Research Institute

Master Protocol: The main goal of this master clinical study is to measure the safety, tolerability, how well it works, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.

NCT07841990 · Official ClinicalTrials.gov record · Gilead Sciences

Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide (TAF), the novel prodrug of tenofovir, another NRTI.

NCT07921472 · Official ClinicalTrials.gov record · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV.

NCT07925307 · Official ClinicalTrials.gov record · University of California, San Diego