Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
NCT05373758

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

Led by Massachusetts General Hospital · Updated on 2026-03-19

648

Participants Needed

3

Research Sites

177 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

M

Mbarara University of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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
  • Known virologic failure on protease inhibitors
  • Exposure to integrase strand transfer inhibitors other than dolutegravir

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

RK Khan Hospital Clinic

Durban, South Africa

Actively Recruiting

2

Mbarara City Clinic

Mbarara, Uganda

Actively Recruiting

3

Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic

Mbarara, Uganda

Actively Recruiting

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Research Team

S

Suzanne McCluskey, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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