Chitungwiza

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.

Researchers are exploring how very early intensive antiretroviral therapy (ART), with or without a broadly neutralizing antibody (bNAb), may help infants living with HIV achieve HIV remission, defined as having HIV RNA levels below the detection limit of the test. This Phase I/II study focuses on infants born to mothers with presumed or confirmed HIV infection and aims to evaluate the impact of starting treatment within 48 hours of birth. The study includes two groups: infants born to mothers who received little or no antiretrovirals during pregnancy, and infants confirmed HIV positive shortly after birth who started ART quickly. The study tests seven different intensive therapy regimens involving combinations of nucleoside reverse transcriptase inhibitors (NRTIs), nevirapine (NVP), lopinavir/ritonavir (LPV/r), raltegravir (RAL), dolutegravir (DTG), and monoclonal antibodies VRC01 or VRC07-523LS. Treatments are given orally or by subcutaneous injection depending on the drug. The study is conducted in four steps: initial enrollment and evaluation within 48 hours of birth (Step 1), up to 192 weeks of ART treatment with monitoring and possible treatment interruption if virus suppression is achieved (Step 2), close monitoring during treatment interruption for up to five years (Step 3), and re-initiation of ART with ongoing monitoring if the virus returns or other criteria are met (Step 4). Participants will be closely monitored throughout the study with regular HIV testing, physical exams, and assessments of immune health. Safety monitoring will continue for infants who do not have confirmed infection but received initial treatment. Children who maintain viral suppression will undergo analytic treatment interruption and be followed for viral rebound. Outcome measures include the number of participants who reach HIV remission by week 48. The study may last up to five years for some participants, including long-term follow-up through re-treatment and viral monitoring.