Fort Pierce

Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are evaluating the effectiveness of switching to injectable GS-3242 plus Lenacapavir LEN compared to continuing the oral medication Biktarvy bictegraviremtricitabinetenofovir alafenamide, BFTAF in adults with well-controlled HIV-1 infection. The study has two parts Part A focuses on people in treatment Groups 1, 2, and 3 at Week 35, while Part B focuses on Groups 4 and 3 at Week 26. This phase 2 trial aims to assess the efficacy of these treatments in virologically suppressed people with HIV-1. Participants are randomized to receive either oral loading doses of GS-3242 combined with LEN tablets followed by intramuscular IM injections of GS-3242 and LEN for up to 52 weeks, at different doses depending on the group, or to continue daily oral BFTAF for up to 52 weeks. Part B participants are enrolled non-randomized to receive oral loading doses and IM injections of GS-3242 and LEN at specific doses. The study compares these treatment approaches to evaluate viral control over specified time points. During the study, participants will have their HIV-1 RNA levels monitored at Week 26, Week 35, and Week 52 using the FDA Snapshot Algorithm to measure viral suppression. Additional assessments include CD4 cell counts, drug concentration levels in blood, and monitoring for treatment-emergent adverse events. The studys total duration extends up to 52 weeks for treatment and includes safety and efficacy evaluations at multiple time points.

Researchers are comparing two forms of long-acting drugs, cabotegravir ultra long-acting CAB ULA plus rilpivirine ultra long-acting RPV ULA versus cabotegravir long-acting CAB LA plus rilpivirine long-acting RPV LA, in adults and adolescents who have HIV and are already virologically suppressed on antiretroviral therapy ART. The study aims to evaluate the effectiveness, safety, and tolerability of these treatments in maintaining viral suppression. Participants are randomly assigned to receive either the CAB ULA plus RPV ULA combination or the CAB LA plus RPV LA combination. Both interventions involve administering these drugs as long-acting injectable treatments. The study is conducted as a phase III trial with parallel groups, where participants continue their assigned treatment regimen throughout the study period. During the trial, participants are monitored regularly to assess their HIV viral load, specifically tracking the percentage of participants with plasma HIV-RNA levels at or above 50 copiesmL at month 11. Additional measures include evaluating virologic failure, drug-related adverse events, and resistance to the study drugs up to month 23. Researchers also track immune cell counts and drug concentrations over time. The total duration of participation extends through to the study completion date, with ongoing safety and efficacy assessments.

Researchers are studying rapid reinitiation of antiretroviral therapy ART with bictegraviremtricitabinetenofovir alafenamide BFTAF in people living with HIV who have interrupted their treatment for at least 12 weeks. The trial aims to evaluate the safety and effectiveness of starting BFTAF on the same day participants return to care. This approach addresses challenges that cause delays in restarting treatment, such as waiting for lab results and multiple medical visits, which may discourage people from resuming care. Participants will receive open-label BFTAF tablets once daily for either 24 or 48 weeks, depending on their viral load at baseline. Those with HIV-1 RNA levels above 50 copiesmL will be treated for 48 weeks, while those with suppressed viral loads below 50 copiesmL will receive 24 weeks of treatment. Treatment begins immediately during the initial visit without waiting for baseline lab results, allowing for rapid reinitiation. The study includes two cohorts based on viral load and optional interviews to understand reasons for treatment interruption and reinitiation. During the study, participants will be monitored through clinical assessments, viral load measurements, CD4 cell counts, safety evaluations, and adherence tracking. Patient-reported outcomes will also be collected to capture experiences with the therapy and treatment satisfaction. Follow-up lasts up to 48 weeks for viremic participants and 24 weeks for suppressed participants, with interviews conducted by teleconference at weeks 4 and 24. The research team will measure how many participants achieve viral suppression and remain engaged in care.

This clinical trial investigates the effectiveness of two different long-acting injectable HIV treatments in adults with well-controlled HIV-1 on daily oral therapy. The study compares a regimen of lenacapavir LEN, teropavimab TAB, and zinlirvimab ZAB given twice a year to cabotegravir CAB and rilpivirine RPV injections given every 8 weeks. The main goal is to evaluate how well these treatments keep the virus suppressed after one year of use. Participants are randomly assigned to one of two treatment groups. One group receives oral LEN and subcutaneous LEN, along with intravenous infusions of TAB and ZAB initially and then every 26 weeks up to 92 weeks. The other group stops their current oral therapy and starts intramuscular injections of CAB and RPV on Day 1, Week 4, and every 8 weeks thereafter for up to 92 weeks. After Week 92, eligible participants may continue LEN, TAB, and ZAB in an extension phase until completion or discontinuation. During the study, participants undergo regular monitoring including HIV-1 RNA measurements to track viral load, CD4 T-cell counts, and assessments for treatment-related adverse events. Researchers will measure the proportion of participants with HIV-1 RNA levels of 50 copiesmL or higher at Week 52 as the primary outcome. Safety and drug concentration levels are also evaluated throughout the study, which may last up to several years including the extension phase.