NCT07193875

Efavirenz (EFV) Intensification

Safety, Tolerability, and Efficacy of Efavirenz (EFV) Intensification on HIV-1 Reservoir Reduction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to see if Efavirenz (EFV) intensification to a baseline combination antiretroviral regimen (cART) can help reduce the size of the latent reservoir in people living with HIV (PLWH). The main questions this study aims to address are: 1. is the addition of EFV to a cART regimen safe and well tolerated? 2. Is there a reduction in the blood and tissue HIV reservoir after intensification? Researchers will compare each participants reservoir size prior to and post EFV intensification.

Detailed description

To evaluate the safety and tolerability of efavirenz (EFV) intensification on the HIV-1 reservoir. Participants with well controlled HIV, specifically with a HIV VL \<500 for at least 48 weeks will be eligible. Prior to enrollment, we will prescreen individuals to ensure they do not have a polymorphism in CY450 which results in rapid metabolism of the study drug efavirenz. Leukapheresis and lymph node (LN) fine needle aspirates will be collected at baseline. Participants eligible to participate will begin taking Efavirenz in addition to their baseline combination antiretroviral therapy. Blood samples (120ml) will be collected twice at day 30 and day 90 for cell associated HIV RNA and HIV DNA assessments. Follow-up LN aspirates and follow-up Leukapheresis will be collected at completion of study, between day 150-180, based on scheduling. At day 90 pharmacokinetic (PK) evaluation of EFV will take place to ensure therapeutic levels of Efavirenz. At the completion of the 180 day course of efavirenz, participants will stop efavirenz but continue their baseline HIV regimen. CD4, HIV VL and monitoring chemistries will be performed at visits on day 30, day 90 and day 150-180.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Efavirenz 600mg	Take One pill daily for 6 months in addition to baseline combination antiretroviral therapy regimen

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study