NCT06747507RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 392 (estimated)
- First submitted
- 18 Dec 2024
- Start date
- 1 Sept 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Nairobi
- Diseases
- HIV
- NCT number
- NCT06747507
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 392
- From 1 Sept 2025 to the primary completion date, Dec 2026
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jaramogi Oginga Odinga Teaching and Referral Hospital Coordinator of this site? Confirm its status | Kisumu | Kenya | Recruiting |
| Bomu Hospital Coordinator of this site? Confirm its status | Mombasa | Kenya | Not yet recruiting |
| Kenyatta National Hospital Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
| Butha Buthe District Hospital Coordinator of this site? Confirm its status | Butha-Buthe | Lesotho | Not yet recruiting |
| Mokhotlong District Hospital Coordinator of this site? Confirm its status | Mokhotlong | Lesotho | Not yet recruiting |
| CS Ponta Gea Coordinator of this site? Confirm its status | Beira | Mozambique | Not yet recruiting |
| CS Machava II Coordinator of this site? Confirm its status | Maputo | Mozambique | Not yet recruiting |
| CS Ndlavela Coordinator of this site? Confirm its status | Maputo | Mozambique | Not yet recruiting |
| MUHAS Clinical Trial Unit Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.