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

Phase 4

Terminated

• Conditions: HIV
• Interventions: Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

• Registration Number: NCT01602822
• Lead Sponsor: Kenneth H. Mayer, MD

Brief 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Results First Submitted: 2015-08-10
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Results First Posted: 2025-04-02
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atazanavir, Ritonavir, Truvada	Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir	Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Primary Outcome Measures

Name	Time	Method
Safety of Regimen - Symptoms	Visit 3- Day 30	Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.
Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related	visit 3 - day 30	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.
Safety of Regimen - Unsafe Biological Test	visit 3 - day 30	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.

Secondary Outcome Measures

Name	Time	Method
Awareness of NPEP	Visit 2- Day 14	Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure
Adherence Rate - Overall	Visit 3- Day 30	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).
Prior nPEP Use	Visit 2- Day 14	Number of participants who had used nPEP prior to participation in the study.

Trial Locations

Locations (1)

Fenway Health; 🇺🇸 Boston, Massachusetts, United States