Summary

Eligibility
for people ages 15 years and up (full criteria)
Dates
study started
estimated completion

Description

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 first-line 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

Details

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 above who have had two HIV-1 RNA viral load results >1,000 copies/mL while on TLD as first-line antiretroviral therapy and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms : 1) Maintenance on TLD with switch to protease inhibitor (PI)-based second-line ART if virologic failure persists past six months, 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic and prior exposure to non-nucleoside reverse transcriptase inhibitors. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition.

Keywords

HIV Infections AIDS Virologic Failure ART Medication Adherence Drug resistance Dolutegravir Maintenance on TLD treatment strategy Individualized Care treatment strategy Immediate Switch Maintenance on TLD

Eligibility

You can join if…

Open to people ages 15 years and up

  • 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 as first-line ART for at least 12 months
  • Lives within 100 kilometers of study clinic
  • Pregnant women are eligible for enrollment.

You CAN'T join if...

  • 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
  • On TLD as second-line or third-line ART

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
ID
NCT05373758
Study Type
Interventional
Participants
Expecting 648 study participants
Last Updated