Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir
University of Nairobi
392 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria5
- Pregnant or breastfeeding
- 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
- 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
Interventions
Dose will be based on weight; brand names will be as supplied through the respective national programs
Dose will be based on weight
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06747507