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

Kenneth H. Mayer, MD

Status and phase: Terminated; Phase 4

Conditions: HIV

Treatments: Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01602822

BMS PEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Atazanavir, Ritonavir, Truvada

Other group

Description:

Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Treatment:

Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir