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

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 9, 2022

Keywords

ClinConnect Summary

The RESOLVE trial is a study aimed at finding the best way to help people with HIV who are not achieving viral suppression while on their first-line treatment, which includes medicines called tenofovir, lamivudine, and dolutegravir (often referred to as TLD). Researchers are particularly focused on people living in Uganda and South Africa who have had high levels of the virus in their blood (more than 1,000 copies/mL) while being treated with TLD for at least 12 months. The main goal is to see if they can reduce the virus to less than 50 copies/mL within 48 weeks.

To participate in this study, individuals must be at least 15 years old, currently receiving HIV care at one of the participating clinics, and have had two recent high viral load readings while on TLD. Pregnant women are welcome to join as well. Participants can expect to receive close monitoring and support throughout the trial. It's important to note that individuals who plan to leave the clinic or move away within the next 48 weeks cannot join the study. This trial is currently recruiting participants, and everyone is welcome regardless of gender.

Gender

ALL

Eligibility criteria

• 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.