Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
Recruiting · NCT06747507 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Nairobi
View the official record on ClinicalTrials.gov →Interventions studied
Darunavir+RitonavirDolutegravir Pill
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.
Who can take part
Age range
3 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
9 locations listed.
- Butha-Buthe District Hospital - Butha-Buthe, Lesotho
- MUHAS Clinical Trial Unit - Dar es Salaam, Tanzania
- Jaramogi Oginga Odinga Teaching and Referral Hospital - Kisumu, Kenya
- CS Machava II - Maputo, Mozambique
- CS Ndlavela - Maputo, Mozambique
- Mokhotlong District Hospital - Mokhotlong, Lesotho
- Bomu Hospital - Mombasa, Kenya
- Kenyatta National Hospital - Nairobi, Kenya
- CS Ponta Gea - Beira, Sofala, Mozambique