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Ongoing Clinical Trials for HIV Infection

This article provides an overview of 65 ongoing clinical trials focused on HIV infection. These studies are exploring new treatments, prevention strategies, and management approaches for people living with or at risk of HIV. The trials span multiple countries and involve various medication regimens, including both oral and injectable therapies, as well as vaccines and prevention methods.

Clinical trial locations

Study Comparing Doravirine and Dolutegravir-Based Treatments for People with HIV-1 Who Have Not Yet Started Therapy

This study is evaluating two different treatment approaches for people newly diagnosed with HIV-1 who have not yet received treatment. Participants will be randomly assigned to receive either Delstrigo (containing doravirine, lamivudine, and tenofovir disoproxil) or a combination of dolutegravir with emtricitabine and tenofovir disoproxil.

Main inclusion criteria: Participants must be at least 18 years old, have confirmed HIV-1 infection, and have a viral load of at least 1,000 copies/mL. They should not have received any previous HIV treatment and must be willing to use effective contraception if applicable.

Main exclusion criteria: People who have previously received HIV treatment, those with a viral load below 1,000 copies/mL, or those considered part of a vulnerable population cannot participate.

Trial focus: The study aims to determine whether doravirine-based treatment is as effective as dolutegravir-based treatment in reducing viral load to undetectable levels. Participants will take their assigned medication daily for 24 months, with regular monitoring of viral load, immune function, and potential side effects.

Investigational drugs: The study evaluates doravirine and dolutegravir, both integrase inhibitors that block HIV replication, along with companion medications lamivudine, emtricitabine, and tenofovir.

Study of Bictegravir and Lenacapavir for Children and Adolescents with HIV-1

This trial examines the safety and effectiveness of combining bictegravir and lenacapavir in children and adolescents with HIV-1. The medications are provided as oral tablets, with the goal of achieving and maintaining viral suppression.

Main inclusion criteria: Participants must be between 12-17 years (weighing ≥35 kg), 6-11 years (25-34 kg), or 2-5 years (10-24 kg). They must be on antiretroviral therapy with HIV-1 RNA below 50 copies/mL, have adequate kidney function, normal blood counts, and show no resistance to the study drugs.

Main exclusion criteria: Children not meeting the weight and age requirements, those without HIV-1 infection, or those from vulnerable populations unable to provide assent are excluded.

Trial focus: The study monitors participants for up to 12 weeks after starting treatment, assessing viral suppression, safety, tolerability, and drug levels in the blood. It also evaluates patient acceptability through questionnaires.

Investigational drugs: Bictegravir (an integrase inhibitor) and lenacapavir (a capsid inhibitor) work together to prevent HIV from multiplying and help maintain viral control.

Study of IMC-M113V for Patients with Chronic HIV Infection Who Are Virologically Suppressed

This study evaluates IMC-M113V, a broadly neutralizing antibody, in people with chronic HIV who have maintained viral suppression on antiretroviral therapy (ART) for at least 12 months.

Main inclusion criteria: Participants must be 18-65 years old, weigh at least 50 kg, be HLA-A*02:01-positive, have HIV-1 RNA below 50 copies/mL for 12 months, maintain CD4+ count above 500 cells/μL, and agree to contraception throughout the study.

Main exclusion criteria: Those not on stable ART for at least 6 months, individuals outside the age range, or those from vulnerable populations are excluded.

Trial focus: The study involves two phases: single ascending dose (SAD) over 10 days and multiple ascending dose (MAD) up to 12 weeks. Participants continue ART while receiving IMC-M113V injections, with regular monitoring of safety, viral load, and immune response.

Investigational drugs: IMC-M113V is a broadly neutralizing antibody designed to target HIV-1 and help maintain viral control in people already on effective ART.

Study of Injectable Cabotegravir Compared to Oral Emtricitabine/Tenofovir for HIV Prevention in Men Who Have Sex with Men

This prevention study compares long-acting injectable cabotegravir (given every 2 months) with daily oral Truvada (emtricitabine/tenofovir) for HIV prevention in men who have sex with men in France.

Main inclusion criteria: Participants must be at least 18 years old, cisgender men who have sex with men, and have been taking oral PrEP (TDF/FTC) for at least 6 months with documented prescription. They must be affiliated with a social security scheme.

Main exclusion criteria: Current HIV infection, previous PrEP use in the last 12 months (other than oral TDF/FTC), age restrictions, known allergies to study medications, serious kidney problems, active hepatitis B, significant liver abnormalities, and inability to follow study procedures are grounds for exclusion.

Trial focus: Over 24 months, the study evaluates how well participants maintain their prevention regimen with each method. Participants receive either monthly oral tablets or bi-monthly injections, with regular monitoring for HIV infection, side effects, and treatment satisfaction.

Investigational drugs: Cabotegravir is administered as a long-acting injection every 2 months, while Truvada (emtricitabine/tenofovir) is taken as a daily oral tablet. Both work by preventing HIV from establishing infection.

Study of Long-Acting Cabotegravir and Rilpivirine for People Aged 60 and Over Living with HIV-1

This trial evaluates long-acting injectable cabotegravir and rilpivirine in people aged 60 and over who are managing their HIV-1 with oral antiretroviral therapy.

Main inclusion criteria: Participants must be 60 years or older, on stable oral ART without current or past resistance to NNRTI or INI medications, have HIV-1 RNA below 50 copies/mL at screening, and provide written informed consent. Women must have negative pregnancy tests and agree not to breastfeed.

Main exclusion criteria: People not on stable oral ART, those with plasma HIV-1 RNA levels of 50 copies/mL or higher, individuals under age 60, and those from vulnerable populations are excluded.

Trial focus: Participants switch from oral medications to long-acting injections of cabotegravir (600 mg) and rilpivirine (900 mg) given intramuscularly. The study runs for 96 weeks, with regular monitoring of viral suppression, safety, and tolerability.

Investigational drugs: Cabotegravir and rilpivirine are long-acting injectable antiretrovirals administered monthly, offering an alternative to daily oral medications while maintaining viral control.

Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

This study examines immune responses to pneumococcal vaccines (Prevenar 20 and Pneumovax 23) in different groups: young healthy adults, older adults, and people living with HIV. It focuses on how vaccines affect germinal center formation in lymph nodes.

Main inclusion criteria: Participants must be either 20-40 years old OR over 60 years old and in good general health. For those with HIV: must be 20-40 years old, have documented HIV infection, be on antiretroviral therapy, and have viral load less than 200 copies/mL.

Main exclusion criteria: Active infections or fever at vaccination, previous severe allergic reactions to pneumococcal vaccines, recent vaccination (within 30 days), pregnancy or breastfeeding, use of immunosuppressive medications, bleeding disorders, uncontrolled chronic conditions, autoimmune disease, recent blood transfusions, substance abuse, and mental conditions interfering with study compliance are excluded.

Trial focus: Participants receive either Prevenar 20 or Pneumovax 23 as a single intramuscular injection. The study monitors immune response through blood tests and lymph node fluid samples at multiple timepoints (7 days, 28 days, 72 days, and 6 months after vaccination).

Investigational drugs: The study uses pneumococcal vaccines that protect against Streptococcus pneumoniae bacteria, which can cause serious infections like pneumonia and meningitis.

Study of teropavimab (3BNC117-LS) and 10-1074-LS antibodies combined with antiretroviral therapy in patients with primary HIV-1 infection to evaluate viral control

This trial examines whether adding two broadly neutralizing antibodies (3BNC117-LS and 10-1074-LS) to standard antiretroviral therapy can help control HIV-1 in people with primary (early) infection when ART is later interrupted.

Main inclusion criteria: Participants must be 18-70 years old with confirmed primary HIV-1 infection, have HIV-1 RNA at least 10,000 copies/mL, not have started ART before the study (except for pre- or post-exposure prophylaxis), agree to receive COVID-19 vaccination, and use effective contraception. They must also be willing to interrupt ART when required by the study.

Main exclusion criteria: Active or chronic hepatitis B or C, severe allergic reactions to antibody treatments, other serious medical conditions, pregnancy or breastfeeding, use of immunosuppressive medications, active opportunistic infections, recent cancer history, significant organ dysfunction, substance abuse affecting participation, mental health conditions interfering with procedures, recent participation in other trials, and known resistance to current HIV medications are excluded.

Trial focus: Participants start ART and receive intravenous infusions of the two antibodies between 7-10 days after starting treatment. They continue ART for 52-76 weeks, then stop ART for 24 weeks while being closely monitored. The study evaluates whether HIV remains controlled without ART and assesses immune system changes.

Investigational drugs: 3BNC117-LS and 10-1074-LS are laboratory-produced broadly neutralizing antibodies that target different parts of HIV-1, potentially helping maintain viral control when combined with ART.

Study on HIV Treatment Interruption in Children with Perinatal HIV Using Lamivudide and Drug Combination

This study explores treatment interruption in children with perinatally acquired HIV who are virologically suppressed on antiretroviral therapy. It examines what happens when ART is temporarily stopped under careful medical supervision.

Main inclusion criteria: Participants must be 12 years or older with documented HIV-1 infection and written informed consent from parent/guardian. They should have been on the same ART regimen with 3+ drugs for at least 1 year, maintain CD4+ count ≥200 cells/mm³, have HIV-1 RNA below detection limits at specific timepoints, show no resistance to integrase inhibitors, and meet laboratory requirements for hemoglobin, neutrophil count, platelets, liver enzymes, and kidney function. Females must have negative pregnancy tests.

Main exclusion criteria: Those without perinatally acquired HIV, outside the specified age ranges, not meeting clinical trial group criteria, or unable to follow study procedures are excluded.

Trial focus: The study involves multiple ART medications (lamivudine, darunavir, cobicistat, emtricitabine, tenofovir, dolutegravir, rilpivirine, abacavir, bictegravir) with planned treatment interruptions. Participants are monitored for up to 48 weeks to observe viral rebound patterns, changes in the HIV reservoir, and immune responses when ART is stopped and restarted.

Investigational drugs: The study uses various antiretroviral medications and examines analytical treatment interruption (ATI) as a research tool to understand HIV behavior when medication is temporarily stopped.

Study on HIV-1 Patients: Effects of Rilpivirine and Dolutegravir After Stopping Antiretroviral Therapy

This trial investigates immune and genetic factors that might predict viral control in people with HIV-1 who were treated early and then stop antiretroviral therapy. The study examines a dual therapy of rilpivirine and dolutegravir.

Main inclusion criteria: Participants must be 18-60 years old males or females with confirmed HIV-1 seropositive status, started ART during acute HIV infection, maintained stable HIV-RNA below 50 copies/mL, have CD4+ count >350 cells/mm³, show no new AIDS-defining diagnoses, be willing to interrupt ART, and provide written informed consent.

Main exclusion criteria: Those not HIV-1 positive, not treated with effective ART during acute phase, outside the age range, or from vulnerable populations are excluded.

Trial focus: After confirming eligibility, participants undergo analytical treatment interruption while taking rilpivirine and dolutegravir. The study monitors viral rebound patterns, CD4:CD8 ratios, and immune-genetic profiles for up to 21 months to develop predictive algorithms for post-treatment viral control.

Investigational drugs: The study uses antiretroviral therapy (ART) as the treatment regimen, examining what happens when it’s temporarily interrupted in people who started treatment early.

Study on Pomalidomide for HIV Control in Patients on ART and During Treatment Interruption

This trial evaluates whether pomalidomide, an immunomodulatory drug, can help control HIV during analytical treatment interruption in people who are virologically suppressed on antiretroviral therapy.

Main inclusion criteria: Participants must have documented HIV-1 infection, be on combination ART for at least 1 year with the same regimen for 4+ weeks before screening, maintain HIV-1 RNA below 50 copies/mL for over 1 year (with specific allowances for single episodes of 50-500 copies/mL), have CD4+ T-cell count >500 cells/μL at screening and >350 cells/μL in the past 24 months, be able to provide informed consent, and agree to continue ART during Phase I and stop during Phase II. All participants must agree to avoid conception.

Main exclusion criteria: Those without HIV-1 infection, not within the specified age range, and people from vulnerable populations are excluded.

Trial focus: Phase I involves taking pomalidomide capsules while continuing ART to assess safety and immune effects. Phase II involves stopping ART to evaluate pomalidomide’s ability to maintain viral control without medication. Throughout both phases, participants are monitored for HIV-1 RNA levels, CD4 counts, and any adverse effects.

Investigational drugs: Pomalidomide is an immune-enhancing agent being tested for its potential to help maintain HIV control during treatment interruption by modulating the immune system.

Study on Reducing HIV Latent Reservoirs Using High Doses of Lamivudide, Maraviroc, and Dolutegravir Sodium for Patients with HIV Infection

This study evaluates whether high doses of three antiretroviral drugs (lamivudine, maraviroc, and dolutegravir) can reduce the latent HIV reservoir by achieving effective tissue concentrations.

Main inclusion criteria: Participants must have HIV infection with undetectable plasma viral load (less than 50 copies HIV RNA/mL) for at least 12 months prior to inclusion, be on antiretroviral treatment with a triple regimen including an integrase inhibitor, have R5 viral tropism determined in proviral DNA, be 18-65 years old, have liver enzymes (ASAT and ALAT) less than 3 times normal, kidney function (creatinine GFR) >60 mL/min, hemoglobin >10 g/dL, platelets >100,000/mm³, and agree to use protection during sexual activity.

Main exclusion criteria: Those without HIV infection, outside the age range, or from vulnerable populations are excluded.

Trial focus: The open-label, randomized controlled study lasts up to 24 months. Participants receive high doses of the three medications as oral film-coated tablets. The primary goal is measuring changes in the latent cellular reservoir by assessing total and intact proviral DNA (IPDA), evaluating whether intensified dosing can help eliminate the hidden HIV reservoir.

Investigational drugs: High-dose antiretroviral therapy using lamivudine, maraviroc, and dolutegravir sodium is administered to evaluate effects on the HIV latent reservoir.

Summary

These 10 trials represent a diverse range of approaches to HIV treatment and prevention, spanning multiple countries including France, Spain, Italy, Belgium, Germany, Denmark, Netherlands, and Sweden. Several notable patterns emerge from this selection:

Treatment strategies vary significantly, with some studies focusing on simplifying regimens (switching from three-drug to two-drug combinations), while others explore intensification approaches (high-dose therapies to target latent reservoirs). Long-acting injectable medications appear in several trials, offering alternatives to daily oral medications.

Special populations receive focused attention, including children and adolescents, people aged 60 and over, pregnant women, and those with early-stage infection. Prevention studies examine both long-acting injectable and oral pre-exposure prophylaxis options.

Several innovative approaches are being tested, such as broadly neutralizing antibodies, immunomodulatory agents, and treatment interruption strategies aimed at achieving viral control without continuous medication. Studies also address important comorbidities including obesity, cardiovascular risk, and vaccine responses.

The trials demonstrate a comprehensive approach to HIV care, addressing not only viral suppression but also quality of life, treatment convenience, and long-term health outcomes for people living with or at risk of HIV infection.

Ongoing Clinical Trials on HIV infection

  • Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of 10-1074-LS and Teropavimab in Controlling HIV in Patients with Early Stage HIV Infection

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Germany The Netherlands Spain Sweden

  • Study of IMC-M113V for Patients with Chronic HIV Infection Who Are Virologically Suppressed

    Recruiting

    1 1
    Investigated diseases:
    Belgium Spain

  • Study Comparing Doravirine and Dolutegravir-Based Treatments for People with HIV-1 Who Have Not Yet Started Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Reducing HIV Latent Reservoirs Using High Doses of Lamivudine, Maraviroc, and Dolutegravir Sodium for Patients with HIV Infection

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Reducing HIV-HBV Treatment with Darunavir, Ritonavir, and Lamivudine for Patients with Controlled Co-Infection

    Recruiting

    1 1 1
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    Investigated drugs:
    France

  • Study on Semaglutide for Weight Loss in Patients with HIV and Obesity

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Ireland Italy

  • Study on Topiramate for Reactivating Hidden HIV in Patients with HIV on Antiretroviral Therapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on HIV-1 Patients: Effects of Rilpivirine and Dolutegravir After Stopping Antiretroviral Therapy

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Venetoclax for Reducing HIV Reservoir in Patients on Antiretroviral Therapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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