Trial record 15 of 26 for:    " January 25, 2012":" February 24, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been terminated.
(Grade 3 elevation in liver function tests)
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Abbott
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT01602822
First received: February 8, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • Safety of regimen [ Time Frame: Visit 3- Day 30 ] [ Designated as safety issue: Yes ]
    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.).

  • Tolerability of regimen [ Time Frame: Visit 3- Day 30 ] [ Designated as safety issue: Yes ]
    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:
  • Awareness of NPEP [ Time Frame: Visit 5- Day 170 ] [ Designated as safety issue: No ]
    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).

  • Compare adherence rates [ Time Frame: Visit 3- Day 30 ] [ Designated as safety issue: No ]
    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)


Enrollment: 11
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: February 8, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fenway Community Health:
HIV Prevention
NPEP
PEP

Additional relevant MeSH terms:
Ritonavir
Atazanavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014