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

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ClinicalTrials.gov Identifier: NCT01602822
Recruitment Status : Terminated (Grade 3 elevation in liver function tests)
First Posted : May 21, 2012
Last Update Posted : March 7, 2013
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Abbott
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir Drug: Ritonavir, Atazanavir, Truvada Phase 4

Detailed Description:
Participants are given a regimen containing 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,for 28 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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 Non-occupational Prophylaxis Following Potential Exposure to HIV-1
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Atazanavir, Ritonavir, Truvada
Open Label
 Drug: 3 drug regimen: 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
Drug: Ritonavir, Atazanavir, Truvada


Outcome Measures
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Primary Outcome Measures :
  1. Safety of regimen [ Time Frame: Visit 3- Day 30 ]
    Safety and tolerability of the regimen will be assessed by the percentage of participants who at or by visit 3: (1) report moderate-to-severe symptoms on the symptom-directed physical exam, (2) report adverse or serious adverse events that are considered related to the use of the drug regimen, and/or (3) have unsafe biological test results as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.).

  2. Tolerability of regimen [ Time Frame: Visit 3- Day 30 ]
    Safety and tolerability of the regimen will be assessed by the percentage of participants who at or by visit 3: (1) report moderate-to-severe symptoms on the symptom-directed physical exam, (2) report adverse or serious adverse events that are considered related to the use of the drug regimen, and/or (3) have unsafe biological test results as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.).


Secondary Outcome Measures :
  1. Awareness of NPEP [ Time Frame: Visit 5- Day 170 ]
    First we will determine how many participants had initially heard of NPEP prior to the incident exposure, as well as how many participants had ever taken NPEP before. Next, using the McNemar's Test, we will assess pre- and post-test attitudes about NPEP by comparing the proportion of participants who endorsed any level of disagreement with those who endorsed any level of agreement among the seven statements on PEP attitudes from baseline (visit 0) to the 6-month follow-up appointment (visit 5).

  2. Compare adherence rates [ Time Frame: Visit 3- Day 30 ]
    Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. Additionally, if the regimen was not completed as prescribed, we will calculate the proportion adherence (i.e., the number of pills taken compared to the number of pills in the regimen). 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602822


Locations
United States, Massachusetts
Fenway Health
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Kenneth H. Mayer, MD
Bristol-Myers Squibb
Gilead Sciences
Abbott
Investigators
Principal Investigator: Kenneth H Mayer, MD Fenway Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Kenneth H. Mayer, MD, Medica Director, The Fenway Institute, Fenway Community Health
ClinicalTrials.gov Identifier: NCT01602822     History of Changes
Other Study ID Numbers: BMS PEP
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Kenneth H. Mayer, MD, Fenway Community Health:
HIV Prevention
NPEP
PEP

Additional relevant MeSH terms:
Ritonavir
Atazanavir Sulfate
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors