Actively Recruiting
Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Led by University of Nairobi · Updated on 2025-09-11
392
Participants Needed
9
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of Nairobi
Lead Sponsor
I
Instituto Nacional de Saúde, Mozambique
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu, Kenya
Actively Recruiting
2
Bomu Hospital
Mombasa, Kenya
Not Yet Recruiting
3
Kenyatta National Hospital
Nairobi, Kenya, 00100
Actively Recruiting
4
Butha-Buthe District Hospital
Butha-Buthe, Lesotho
Not Yet Recruiting
5
Mokhotlong District Hospital
Mokhotlong, Lesotho
Not Yet Recruiting
6
CS Ponta Gea
Beira, Sofala, Mozambique
Not Yet Recruiting
7
CS Machava II
Maputo, Mozambique
Not Yet Recruiting
8
CS Ndlavela
Maputo, Mozambique
Not Yet Recruiting
9
MUHAS Clinical Trial Unit
Dar es Salaam, Tanzania
Not Yet Recruiting
Research Team
J
Joseph Nkuranga, MBChB, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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