NCT03877536

Antiretroviral Therapy for Acute HIV Infection

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.

Detailed description

This is a prospective, open-label study to describe the effects of early antiretroviral (ART) therapy on 1) viral load, 2) safety and tolerability of Genvoya®, 3) clinical outcomes and secondarily on HIV-specific immune responses. This study is a sub-study of RV 217 that will recruit participants with incident HIV diagnoses from the parent RV 217 cohort. Potential RV 392 volunteers will be recruited from the RV 217 ECHO cohort if they have been diagnosed with incident HIV Infection. Screening procedures for HIV in RV 217 are designed to identify participants during acute HIV infection (AHI) or early HIV infection. Participants will initiate Genvoya®, a once a day antiretroviral pill within 1 week of enrollment. RV 392 follow-up visits will largely overlap with RV 217 visits for the study duration of 96 weeks, but additional visits will occur early after initiation of Genvoya®. RV 392 participants will remain co-enrolled in RV 217 (i.e., RV 217 visits also continue); blood collection will be coordinated by the RV 392 team by prioritizing safety labs and then research labs within the allotted blood volumes while still meeting scientific objectives for both RV 217 and RV 392. Blood tests that are required for both protocols will only be collected once and will not be duplicated across the two protocols.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Genvoya 150Mg-150Mg-200Mg-10Mg Tablet	Participants will receive 1 tablet per day throughout study duration (96 weeks).

Timeline

• Start date: 2019-03-17
• Primary completion: 2023-09-14
• Completion: 2025-09-14
• First posted: 2019-03-15
• Last updated: 2019-04-26

Locations

1 site across 1 country: Uganda