A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure for Individuals on TLD in Sub-Saharan Africa (RESOLVE)
Investigators: Dr. Suzanne McCluskey, Dr. Winnie Muyindike
Study Description: We are recruiting 648 adults with two viral loads >1,000 copies/mL while on first-line TLD for at least 12 months, who are in care at public-sector HIV clinics in Uganda or South Africa. We are randomizing participants to one of the following strategies, stratified by clinic and prior NNRTI-exposure: a) Standard of Care, with regimen guided by genotypic resistance tests and care as per guidelines in Uganda and continuation of TLD and care as per guidelines in South Africa b) Individualized Care, with regimen choice based on results of genotypic resistance tests and urine tenofovir assays c) Immediate Switch to PI-based second-line ART. The primary outcome will be viral suppression (<50 copies/mL) at 48-weeks post-enrollment using the FDA snapshot definition.
We hypothesize that rates of viral suppression at 48 weeks will be higher in the Individualized Care arm than in the Standard of Care and Immediate Switch arms.
In Aim1, we are conducting the RESOLVE Trial, an open, parallel arm, randomized clinical trial to evaluate solutions for the optimal management of virologic failure on first-line TLD in SSA. Aim2, use simulation modeling to examine the clinical impact, costs, and cost-effectiveness of strategies to improve viral suppression after virologic failure on TLD.
