NCT06747507 Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
| NCT ID | NCT06747507 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Nairobi |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 392 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 392 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Loice A Ombajo, MMed, MSc
PRINCIPAL INVESTIGATOR
University of Nairobi
Frequently Asked Questions
Who can join the NCT06747507 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06747507 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 392 participants.
Is NCT06747507 currently recruiting?
Yes, NCT06747507 is actively recruiting participants. Contact the research team at dnkuranga@uonbi.ac.ke for enrollment information.
Where is the NCT06747507 trial being conducted?
This trial is being conducted at Kisumu, Kenya, Mombasa, Kenya, Nairobi, Kenya, Butha-Buthe, Lesotho and 5 additional locations.
Who is sponsoring the NCT06747507 clinical trial?
NCT06747507 is sponsored by University of Nairobi. The principal investigator is Loice A Ombajo, MMed, MSc at University of Nairobi. The trial plans to enroll 392 participants.
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