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Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

RecruitingPhase 3

Sponsor: University of Nairobi

Conditions: HIV-1-infection

Interventions: Dolutegravir Pill, Darunavir+Ritonavir

Countries: Kenya, Lesotho, Mozambique, Tanzania

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 overview

Sex: ALL

Age: 3 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (9)

Kisumu, Kenya
Mombasa, Kenya
Nairobi, Kenya
Butha-Buthe, Lesotho
Mokhotlong, Lesotho
Beira, Sofala, Mozambique
Maputo, Mozambique
Maputo, Mozambique
Dar es Salaam, Tanzania