Actively Recruiting
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
Led by Massachusetts General Hospital · Updated on 2026-03-19
648
Participants Needed
3
Research Sites
177 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
M
Mbarara University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Known virologic failure on protease inhibitors
- Exposure to integrase strand transfer inhibitors other than dolutegravir
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
RK Khan Hospital Clinic
Durban, South Africa
Actively Recruiting
2
Mbarara City Clinic
Mbarara, Uganda
Actively Recruiting
3
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara, Uganda
Actively Recruiting
Research Team
S
Suzanne McCluskey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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