RecruitingNot ApplicableNCT05373758

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

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


Sponsor

Massachusetts General Hospital

Enrollment

648 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

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, 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.


Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different treatment strategies for people with HIV in sub-Saharan Africa whose virus is no longer being suppressed by their current medication regimen (called TLD — tenofovir, lamivudine, and dolutegravir). Researchers want to find the best next treatment when TLD stops working. **You may be eligible if...** - You are 15 or older - You are receiving HIV care at one of the study clinics - You have had two HIV viral load measurements above 1,000 copies/mL while on TLD treatment - You have been on TLD for at least 12 months - You live within 100 km of the study clinic - Pregnant women are eligible to participate **You may NOT be eligible if...** - You plan to transfer to a different clinic or move out of the study area within the next 48 weeks - You have previously had HIV treatment failure on protease inhibitor drugs or have been treated with integrase inhibitors other than dolutegravir Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard of Care treatment strategy

Management of virologic failure on TLD using the Standard of Care strategy

OTHERIndividualized Care treatment strategy

Management of virologic failure on TLD using the Individualized Care strategy

OTHERImmediate Switch

Management of virologic failure on TLD using the Immediate Switch strategy


Locations(3)

RK Khan Hospital Clinic

Durban, South Africa

Mbarara City Clinic

Mbarara, Uganda

Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic

Mbarara, Uganda

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NCT05373758


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