Investigating the Optimal Management of Dolutegravir Resistance an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir

What this Trial Is About

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.

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance