Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

Recruiting now · Phase 3

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT06747507

Run by

University of Nairobi

People needed

392

Starts

2025-09-01

Expected to finish

2027-07-01

Last updated by the study team

2025-09-11

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Jaramogi Oginga Odinga Teaching and Referral Hospital — Kisumu, Kenya (enrolling)
• Kenyatta National Hospital — Nairobi, Kenya (enrolling)
• CS Ponta Gea — Beira, Sofala, Mozambique
• CS Machava II — Maputo, Mozambique
• Butha-Buthe District Hospital — Butha-Buthe, Lesotho
• MUHAS Clinical Trial Unit — Dar es Salaam, Tanzania
• Bomu Hospital — Mombasa, Kenya
• CS Ndlavela — Maputo, Mozambique
• Mokhotlong District Hospital — Mokhotlong, Lesotho

Full record on ClinicalTrials.gov

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