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

NCT01602822 | Terminated Phase 4 Results

• 1 other identifier: BMS PEP
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV Prevention; Non-occupational Post-Exposure Prophylaxis (NPEP); Post-Exposure Prophylaxis (PEP)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Awareness of NPEP

  Visit 2- Day 14

• Adherence Rate - Overall

  Visit 3- Day 30

• Prior nPEP Use

  Visit 2- Day 14

• Adherence - Degree of Adherence

  Visit 1- Day 28

Study Arms (1)

Atazanavir, Ritonavir, Truvada

OTHER

Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Drug: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir

Interventions

Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir 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

Also known as: Truvada

Atazanavir, Ritonavir, Truvada

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 at time of first visit.
• HIV uninfected on the basis of a negative HIV Rapid Test
• 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.

You may not qualify if:

• Women who are actively trying to become pregnant.
• Pregnancy and/or Breastfeeding.
• Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.
• Known intolerance or allergy to study drugs.

Sponsors & Collaborators

• Kenneth H. Mayer, MD: lead
• Bristol-Myers Squibb: collaborator
• Gilead Sciences: collaborator
• Abbott: collaborator

Study Sites (1)

Fenway Health

Boston, Massachusetts, 02215, United States

Location

Related Links

• Fenway Health homepage

MeSH Terms

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Study terminated early as a result of Grade 3 and Grade 4 elevations in liver function tests

Results Point of Contact

• Title: Dr. Kenneth Mayer
• Organization: Fenway Health

kmayer@fenwayhealth.org

617-927-6400

Study Officials

• Kenneth H Mayer, MD

  Fenway Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, The Fenway Institute

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

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: May 21, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 10, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)