Comparing two HIV medicine options for people with dolutegravir drug resistance
Compares staying on dolutegravir with switching to darunavir plus ritonavir in people with HIV-1.
Plain-language title generated from the registry record
Registry title: Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Key facts
- Where
- Butha-Buthe and Mokhotlong, LesothoSee the 2 sites
- Phase
- Phase 3
Where in Lesotho
- Butha Buthe District HospitalButha-Buthe, LesothoNot yet recruiting
- Mokhotlong District HospitalMokhotlong, LesothoNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Nairobi
- Trial code
- NCT06747507
- Record updated
- 11 September 2025
- Original description
This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.Read full original descriptionShow less
Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir
This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.
Inclusion: Enrolled in the Ndovu cohort study; Able and willing to understand and comply with the protocol requirements, instructions and restrictions; Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if < 18 years); Age ≥ 3 years; Most recent HIV-1 RNA ≥ 200 copies/mL; At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K).
Exclusion: Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs; WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening; Pregnant or breastfeeding; Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons; Investigator opinion that the potential participant should not switch to DRV/r for clinical reasons.