Mokhotlong

Researchers are studying people living with HIV-1 infection who are on dolutegravir DTG-based antiretroviral therapy ART but have a viral load above 1,000 copiesmL after at least six months of treatment. The goal is to understand viral suppression rates and the emergence of DTG-associated drug-resistant mutations in these individuals. This multi-country prospective observational study takes place in Kenya, Mozambique, Tanzania, and Lesotho, addressing gaps in data about managing virologic failure without changing the ART regimen. Participants will continue their DTG-based ART for up to 12 months while receiving enhanced adherence counseling if their viral load remains above 200 copiesmL. Study visits and viral load testing happen at enrollment and every three months during the active follow-up period. Enhanced adherence counseling includes at least three sessions per visit to support medication adherence and address other causes of viral increase. The study also collects routine program data for up to 24 months to assess how well viral suppression lasts over time. During the study, participants undergo viral load testing, counseling, and assessments at regular intervals. Researchers will analyze viral suppression rates at 6 and 12 months and evaluate factors that predict suppression or the development of drug resistance. They will also monitor the patterns and timing of drug-resistant mutations and opportunistic infections. The study plans to enroll 6,600 participants and may invite eligible individuals to join a nested randomized clinical trial focusing on managing drug resistance.

Researchers are studying the management of drug resistance in people living with HIV who are on dolutegravir DTG-based antiretroviral therapy but experience treatment failure due to drug-resistant mutations. This phase 3b randomized clinical trial aims to compare the effectiveness and safety of continuing DTG versus switching to ritonavir-boosted darunavir DRVr in patients with HIV-1 RNA levels above 200 copiesmL and at least one major DTG-associated drug resistance mutation. The study addresses gaps in current treatment strategies across several countries. Participants will be randomly assigned to one of two groups one will continue their existing DTG-based ART regimen, and the other will switch to a DRVr-based ART regimen. The dosing will be based on weight, and the study will take place over 12 months at multiple sites in Kenya, Mozambique, Tanzania, and Lesotho. The primary measure is the proportion of participants achieving viral suppression with HIV-1 RNA below 200 copiesmL at 6 months. During the trial, participants will have regular monitoring of their viral load and drug resistance mutations, along with assessments of treatment adherence, safety, and patient satisfaction. Additional outcomes include viral suppression rates at 12 months, incidence of adverse events, and changes in CD4 counts. The study includes children aged 3 years and older and plans to enroll 392 participants. Follow-up and data collection will support understanding optimal treatment management for this population.