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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people already in the Ndovu cohort study who have detectable HIV and a dolutegravir-related resistance change. It compares staying on dolutegravir with switching to ritonavir-boosted darunavir.
- Age
- 3 years and older
- Sex
- All sexes can join.
- Disease stage
- Most recent HIV-1 RNA of 200 copies/mL or more.
- Earlier treatment
- Taking a dolutegravir (DTG)-based antiretroviral regimen before joining.
- Biomarker or test result
- At least one major DTG-associated resistance mutation (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K).
Main reasons for not taking part
- Pregnant or breastfeeding
- Using any other therapy not allowed with the study drugs
- WHO stage 3 or 4 opportunistic infection within 4 weeks before screening that would prevent randomisation
- Investigator's opinion that DTG should be stopped immediately for clinical reasons
- Investigator's opinion that switching to DRV/r is not advisable for clinical reasons
Read by machine on 9 November 2026.
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.