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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

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE May 21, 2012
Last Update Posted Date March 7, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • 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.).
  • 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.).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01602822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
  • 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).
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
Official Title  ICMJE 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
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 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 Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE
  • 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
Study Arms Atazanavir, Ritonavir, Truvada
Open Label
Interventions:
  • Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
  • Drug: Ritonavir, Atazanavir, Truvada
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)
11
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2012)
120
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602822
Other Study ID Numbers  ICMJE BMS PEP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kenneth H. Mayer, MD, Fenway Community Health
Study Sponsor  ICMJE Kenneth H. Mayer, MD
Collaborators  ICMJE
  • Bristol-Myers Squibb
  • Gilead Sciences
  • Abbott
Investigators  ICMJE
Principal Investigator: Kenneth H Mayer, MD Fenway Health
PRS Account Fenway Community Health
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP