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

Phase 4TerminatedNCT01602822

Kenneth H. Mayer, MD11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

HIV

Interventions

Tenofovir DF and Emtricitabine; Ritonavir-boosted AtazanavirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fenway Health

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Safety of Regimen - Symptoms

Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.

Time frame: Visit 3- Day 30

Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related

Number of subjects who experience adverse or serious adverse events that are considered related to the use of the drug regimen at or before visit 3.

Time frame: visit 3 - day 30

Safety of Regimen - Unsafe Biological Test

Number of subjects who have an unsafe biological test result as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.) at or before visit 3.

Time frame: visit 3 - day 30

Secondary Outcomes

Awareness of NPEP

Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure

Time frame: Visit 2- Day 14

Adherence Rate - Overall

Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. χ2 tests will be used to assess differences in the proportion of both completion and adherence between participants in the current study and participants in previous studies of NPEP at Fenway Health (historical controls).

Time frame: Visit 3- Day 30

Prior nPEP Use

Number of participants who had used nPEP prior to participation in the study.

Time frame: Visit 2- Day 14

Adherence - Degree of Adherence

Data from ClinicalTrials.gov

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