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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atazanavir, Ritonavir, Truvada

Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Group Type OTHER

Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Truvada

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes