NCT01602822

Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV

A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Kenneth H. Mayer, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Detailed description

Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir	TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-05-21
• Last updated: 2025-07-10
• Results posted: 2025-04-02

Locations

1 site across 1 country: United States