MedTrace Logo

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

NCT05373758 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • AIDS
  • Virologic Failure

Interventions

OTHER

Standard of Care treatment strategy

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

OTHER

Individualized Care treatment strategy

Management of virologic failure on TLD using the Individualized Care strategy

OTHER

Immediate Switch

Management of virologic failure on TLD using the Immediate Switch strategy

Sponsors & Collaborators

  • Mbarara University of Science and Technology

    collaborator OTHER

  • University of KwaZulu

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Suzanne McCluskey, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373758 on ClinicalTrials.gov