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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the long-term use of a long-acting injectable drug called cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in people at risk of acquiring HIV. This study focuses on participants who have completed or are currently enrolled in previous related studies HPTN 083 and HPTN 084 and their sub-studies. The goal is to monitor new HIV infections, serious adverse events, injection site reactions, and other adverse events that might cause withdrawal over an extended period. Participants will receive CAB LA by gluteal intramuscular injection at a dose of 600 mg every 8 weeks. This treatment continues from the parent studies, and participants will be followed for up to approximately 3 years. The study includes ongoing treatment with CAB LA and regular assessments to evaluate safety and effectiveness as part of this long-term follow-up. During the study, participants will undergo regular HIV testing, safety monitoring, and evaluation of injection site reactions and adverse events. Researchers will track the number of new HIV infections and detailed characteristics of these infections from the start of the study through the follow-up period. This includes monitoring serious and grade 3 or 4 injection site reactions, as well as other adverse events that may lead to withdrawal from the study. Participants will be observed closely to ensure continued safety throughout the study duration.
Actively Recruiting
Researchers are evaluating the impact of a combination of three broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children living with HIV-1 in Botswana. This phase I/II trial aims to advance pediatric HIV treatment and cure research by studying these effects in young participants who started antiretroviral therapy early. Participants receive intravenous infusions of the antibodies PGDM1400LS, VRC07-523LS, and PGT121.414.LS based on their weight. They continue their existing effective antiretroviral therapy (ART) during initial study steps. Later study phases include periods of antibody immunotherapy alone after stopping ART, and some participants may undergo analytic treatment interruption where all anti-HIV treatments are paused. The study monitors safety and treatment effects through these various steps and durations. During the study, participants undergo regular assessments including viral load measurements, CD4 cell counts, and safety evaluations over periods lasting up to 48 weeks. Researchers track the maintenance of HIV suppression, immune function, and safety of the antibody therapies alone or combined with ART. Participants will be followed through multiple steps, including periods of antibody treatment with ART, antibody treatment alone, and treatment interruption, to understand long-term effects and safety.