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

HIV Infections Clinical Trial

— RESOLVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373758
• Other study ID #: 2022P001193
• Secondary ID: R01AI167699
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Suzanne McCluskey, MD
• Phone: 617-726-9488
• Email: smccluskey[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 first-line 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.

Description:

The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results >1,000 copies/mL while on TLD as first-line antiretroviral therapy and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; continuation of TLD and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic and prior exposure to non-nucleoside reverse transcriptase inhibitors. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to <50 copies/mL at 48 weeks using the FDA snapshot definition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 648
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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 as first-line ART for at least 12 months

• Lives within 100 kilometers of study clinic

• Pregnant women are eligible for enrollment.

Exclusion Criteria:

• 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

• On TLD as second-line or third-line ART

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• Virologic Failure

Intervention

Other:
• Standard of Care treatment strategy
Management of virologic failure on TLD using the Standard of Care strategy
• Individualized Care treatment strategy
Management of virologic failure on TLD using the Individualized Care strategy
• Immediate Switch
Management of virologic failure on TLD using the Immediate Switch strategy

Locations

Country	Name	City	State
South Africa	RK Khan Hospital Clinic	Durban
Uganda	Mbarara City Clinic	Mbarara
Uganda	Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic	Mbarara

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mbarara University of Science and Technology, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco, University of KwaZulu

Countries where clinical trial is conducted

South Africa,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)