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.
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
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.
Parallel
Standard of Care treatment strategy
Other interventionManagement of virologic failure on TLD using the Standard of Care strategy
Individualized Care treatment strategy
Other interventionManagement of virologic failure on TLD using the Individualized Care strategy
Immediate Switch
Other interventionManagement of virologic failure on TLD using the Immediate Switch strategy
Viral suppression at 48 weeks
A plasma HIV-1 RNA viral load \<50 copies/mL (FDA-snapshot definition)
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Massachusetts General Hospital
Lead sponsor
Mbarara University of Science and Technology
Collaborator
University of KwaZulu
Collaborator
University of California, San Francisco
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Bill and Melinda Gates Foundation
Collaborator
