At a glance
ClinicalIndex Comparison Record- ✓HIV-negative man with receptive anal sex with another man in the last 6 months
- ✓Age 18-49 years
- ✓Not currently taking PrEP and no plans to initiate during study
- ✓Not currently taking PEP
- ✕History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract
- ✕Currently infected with hepatitis virus and/or have liver disease
- ✕Current or chronic history of kidney disease
- ✕Use of aspirin or more than 4 doses of NSAIDs in the 14 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ART Persistence: Antiretroviral Drug Persistence in Different Body Compartments in HIV Negative Men Who Have Sex With Men
In Brief
A Phase 4 clinical trial evaluating Biktarvy for ART and HIV. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how long it persists in different body compartments, including mucosal tissues, as it may be considered for PrEP or PEP regimens in the future.
Study Details
Timeline
Interventions
Participants will be given two doses of the oral fixed dose combination anti-HIV medication Biktarvy (BIC/FTC/TAF) separated by 24 hours. The first dose is given in the clinic and participants are instructed to take the second dose at home, 24 hours after the first dose.