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

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth H. Mayer, MD
• Collaborators: Abbott; Bristol-Myers Squibb; Gilead Sciences
• Treatments: Atazanavir Sulfate; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

1. Age of 18 at time of first visit.

2. HIV uninfected on the basis of a negative HIV Rapid Test

3. Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.

Exclusion Criteria:

1. Women who are actively trying to become pregnant.

2. Pregnancy and/or Breastfeeding.

3. Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.

4. Known intolerance or allergy to study drugs.