Status:
RECRUITING
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Mbarara University of Science and Technology
University of KwaZulu
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
15+ years
Phase:
NA
Brief 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, l...
Detailed Description
The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and ab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT05373758
Start Date
February 7 2024
End Date
May 1 2027
Last Update
March 5 2025
Active Locations (3)
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1
RK Khan Hospital Clinic
Durban, South Africa
2
Mbarara City Clinic
Mbarara, Uganda
3
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara, Uganda