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

February 8, 2012
March 6, 2013
February 2012
May 2012   (final data collection date for primary outcome measure)
  • 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.).
Same as current
Complete list of historical versions of study NCT01602822 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
  • 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
Atazanavir, Ritonavir, Truvada
Open Label
Interventions:
  • Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
  • Drug: Ritonavir, Atazanavir, Truvada
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01602822
BMS PEP
No
Kenneth H. Mayer, MD, Fenway Community Health
Kenneth H. Mayer, MD
  • Bristol-Myers Squibb
  • Gilead Sciences
  • Abbott
Principal Investigator: Kenneth H Mayer, MD Fenway Health
Fenway Community Health
March 2013

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