HIV-1 INFECTION

This study is for children aged 2 to 12 who have HIV and whose virus is already under control with daily pills. The goal is to see if switching to a long-acting injectable medication (shots every 4 or 8 weeks) is safe, tolerable, and works as well as pills. About 90 children will…

This study tests whether a combination of two antibodies (TMB-365 and TMB-380) given as an IV infusion every 8 weeks can keep HIV under control in people who are already suppressed on daily oral medication. About 75 adults with HIV will either switch to the antibody infusions or …

This study tests a new experimental drug, CL-197, in 24 adults with HIV-1 who have never taken any HIV medication before. The goal is to see how well the drug lowers the amount of virus in the blood and to check for side effects over about two weeks. Participants will receive a s…

This early-stage study tests a lab-made antibody called BNT351 in up to 61 adults, both with and without HIV. The main goals are to check safety, how long the antibody stays in the body, and whether it can lower HIV levels in people with the virus. This is not a cure—participants…

This study looks at whether semaglutide, a weight loss drug, can help people with HIV who are obese lose more weight than just diet and exercise. About 80 adults with well-controlled HIV will take semaglutide or follow lifestyle changes alone for 28 weeks. Researchers will also c…

This study tests a long-acting HIV medicine called lenacapavir in teens and children (weighing at least 35 kg) who have tried other HIV drugs before. The goal is to see if the drug is safe, tolerable, and works well when combined with other HIV medications. Participants will rece…

This study looks at people with HIV whose virus has become resistant to the drug dolutegravir. It compares two options: staying on dolutegravir or switching to another drug called darunavir boosted by ritonavir. The goal is to see which approach better controls the virus. About 3…

This study compares two different HIV medication combinations in people who have never taken HIV drugs before. One group gets doravirine plus tenofovir and lamivudine, the other gets dolutegravir plus tenofovir and either lamivudine or emtricitabine. The goal is to see if the dor…

This study tests a new two-drug combination (bictegravir/lenacapavir) for children and teens with HIV-1 whose virus is already under control with complex daily meds. About 75 participants aged 2 to 17 will receive the study drug to see if it is safe and how the body processes it.…

This study looks at whether a medication called SGLT2 inhibitor, already used for diabetes and kidney disease, can improve blood flow to the heart in women with HIV who also have diabetes or kidney problems. About 80 women will be randomly assigned to health education alone or he…

This study tests whether a special HIV vaccine, combined with an immune booster (vesatolimod) and two powerful antibodies, can help people with HIV control the virus after stopping their daily antiretroviral therapy. The trial involves 36 adults who started HIV treatment very ear…

This early-stage study tests a new experimental HIV medicine, GS-3242, in 30 people living with HIV-1. The goal is to see how safe it is, how the body processes it, and how well it lowers the amount of virus in the blood over 11 days. Participants must have a certain level of vir…

This study tests a phone-based therapy called Acceptance and Commitment Therapy (ACT) to help people with HIV who drink too much. Researchers will compare ACT to a standard brief intervention in 300 adults. The goal is to see if ACT reduces alcohol use and improves symptoms of de…

This study offers continued access to HIV medications for up to 350 children and teens who completed a previous Gilead HIV treatment study. Participants may stay on their current drug or switch to a newer combination pill. The main goal is to ensure they keep receiving treatment …

This study checks how well a new rapid test (TruPlex) works for detecting HIV, hepatitis B, and syphilis. Trained staff will use the test on about 1000 adults at clinics or near-patient settings. The goal is to see if the test is accurate, easy to use, and correctly interpreted.

This study follows 5,000 HIV-negative adults in Italy who are taking or starting PrEP, a daily pill that prevents HIV. Researchers will track how well PrEP works in real life, how often people take it, and any side effects. The goal is to gather data to help eliminate new HIV inf…

This early-stage study tests a new vaginal gel called MucoCept-CVN in 12 healthy women. The gel contains a modified version of a natural vaginal bacterium that continuously produces a potent anti-HIV drug. The goal is to see if it is safe and can be cleared with antibiotics, pavi…

This study tests whether adding the drug tesamorelin to a home exercise program improves physical function in adults aged 50-80 with HIV who are sedentary and show early signs of frailty. Half of the 100 participants will get tesamorelin and half a placebo, all while exercising w…

This study looks at how mothers with HIV in the United States decide to feed their babies, whether by breastfeeding or formula. Researchers will interview and survey about 1,150 mothers and their families to understand the medical, social, and personal factors behind these choice…

This study looks at 6,600 people with HIV whose current dolutegravir-based treatment is not working well (virus levels high). Researchers want to see if extra counseling helps lower the virus, and how drug resistance changes over time. The goal is to find better ways to manage tr…

This study looks at how cannabis ingredients (THC and CBD) affect decision-making, attention, and motivation in people with and without HIV. About 138 adults aged 18-65 who use cannabis infrequently will take either THC, CBD, or a placebo for 5 days and then complete thinking tes…

This study looks at how a type of talk therapy for depression changes the gut microbiome, immune system, and brain function in people living with HIV. Researchers will enroll 150 adults with HIV and depression to understand these connections. The goal is to learn more about how t…