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

A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1

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.

Study Overview

• Status: Terminated
• Conditions: HIV
• Intervention / Treatment: Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atazanavir, Ritonavir, Truvada; Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir	Drug: 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; Other Names: Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Regimen - Symptoms	Number of subjects who experienced moderate-to-severe symptoms on the symptom-directed physical exam at or before visit 3.	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.	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.	visit 3 - day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness of NPEP	Assess awareness as measured by how many participants had initially heard of NPEP prior to the incident exposure	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).	Visit 3- Day 30
Prior nPEP Use	Number of participants who had used nPEP prior to participation in the study.	Visit 2- Day 14
Adherence - Degree of Adherence	Number of participants who completed prescribed regimen	Visit 1- Day 28

Collaborators and Investigators

• Sponsor: Kenneth H. Mayer, MD
• Collaborators: Bristol-Myers Squibb; Gilead Sciences; Abbott
• Investigators: Principal Investigator: Kenneth H Mayer, MD, Fenway Health

Publications and helpful links

Helpful Links

• Fenway Health homepage

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimated): May 21, 2012

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HIV Prevention; Post-Exposure Prophylaxis (PEP); Non-occupational Post-Exposure Prophylaxis (NPEP)
• Additional Relevant MeSH Terms: Viral Protease Inhibitors; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Tenofovir; Emtricitabine; Atazanavir Sulfate; Ritonavir
• Other Study ID Numbers: BMS PEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified participant data describing the adverse events will be available for review upon request