A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa
RESOLVE
2 other identifiers
interventional
648
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Feb 2024
Typical duration for not_applicable hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 13, 2022
CompletedStudy Start
First participant enrolled
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 19, 2026
March 1, 2026
3.4 years
May 6, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Viral suppression at 48 weeks
A plasma HIV-1 RNA viral load \<50 copies/mL (FDA-snapshot definition)
48 weeks post-enrollment (visit window spanning 42 to 54 weeks post-enrollment)
Study Arms (3)
Standard of Care
EXPERIMENTALIn Uganda, participants will be managed per Ministry of Health (MOH) guidelines. GRT is performed by MOH for individuals with virologic failure on TLD. Participants will continue enhanced adherence counseling (EAC) and TLD while awaiting the GRT result. Treatment decision will be made by the regional switch committee when GRT results return. There will be a Week 24 visit for specimen collection. In South Africa, participants will be managed per Department of Health (DOH) guidelines. Some individuals will be eligible for GRT (performed by DOH) based on ART duration and adherence per DOH guidelines. Treatment decision will be made by the clinic when GRT results return. Individuals who are ineligible for GRT will undergo EAC and continue on TLD. At Weeks 24, participants will undergo plasma HIV-1 RNA viral load testing. Results will be returned to the clinic team for patient management per DOH guidelines. All participants undergo viral load testing at Week 48.
Individualized Care
EXPERIMENTALParticipants will undergo routine EAC, point-of-care urine tenofovir (TFV) testing, and genotypic resistance testing (GRT) at enrollment. Participants will return when GRT results are available for a treatment decision. Side effects and tolerance will also be assessed. All information will be used to make an optimal treatment recommendation with participant input. Participants will have an additional study visit at Week 24 and will continue to have routine care visits, adherence counseling by the clinic, and viral load monitoring at intervals determined by the clinic per national guidelines. Participants will undergo plasma HIV-1 RNA viral load testing at Week 48.
Immediate Switch
EXPERIMENTALParticipants will undergo routine EAC and a switch from TLD to PI-based second-line ART at the enrollment visit (Week 0). Participants will have an additional study visit at Week 24. Participants will continue to have routine care visits and viral load monitoring at intervals determined by the clinic per national guidelines. At study completion, participants will undergo plasma HIV-1 RNA viral load testing at Week 48.
Interventions
Management of virologic failure on TLD using the Immediate Switch strategy
Management of virologic failure on TLD using the Standard of Care strategy
Management of virologic failure on TLD using the Individualized Care strategy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify 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
- As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of KwaZulucollaborator
- University of California, San Franciscocollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Massachusetts General Hospitallead
- Mbarara University of Science and Technologycollaborator
- Bill and Melinda Gates Foundationcollaborator
Study Sites (3)
RK Khan Hospital Clinic
Durban, South Africa
Mbarara City Clinic
Mbarara, Uganda
Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic
Mbarara, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne McCluskey, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 13, 2022
Study Start
February 7, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03