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A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa

RecruitingNAAges 15 Years - anyAllMassachusetts General Hospital
NCT05373758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 15 years and above * Enrolled in HIV care at one of the study clinics * History of two HIV-1 RNA viral load measurements \>1,000 copies/mL while on TLD * On TLD for at least 12 months * Lives within 100 kilometers of study clinic * Pregnant women are eligible for enrollment. Exclusion Criteria: * Plans to transfer out of the clinic within the next 48 weeks * Plans to move out of the study catchment area within the next 48 weeks * As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
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What it tests

  • Standard of Care treatment strategy
  • Individualized Care treatment strategy
  • Immediate Switch
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Where

3 sites
RK Khan Hospital Clinic
Durban, South Africa
Mbarara City Clinic
Mbarara, Uganda
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara, Uganda
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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