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A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
Sponsor: Massachusetts General Hospital
Summary
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.
Official title: A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on Tenofovir, Lamivudine, and Dolutegravir (TLD) in Sub-Saharan Africa
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
648
Start Date
2024-02-07
Completion Date
2027-06-30
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Standard of Care treatment strategy
Management of virologic failure on TLD using the Standard of Care strategy
Individualized Care treatment strategy
Management of virologic failure on TLD using the Individualized Care strategy
Immediate Switch
Management of virologic failure on TLD using the Immediate Switch strategy
Locations (3)
RK Khan Hospital Clinic
Durban, South Africa
Mbarara City Clinic
Mbarara, Uganda
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara, Uganda