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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Ritonavir Atazanavir Atazanavir sulfate Truvada

U.S. FDA Resources

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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Related Info This link exits the ClinicalTrials.gov site

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:


Atazanavir Emtricitabine Ritonavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents	Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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