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

Sponsor

Kenneth H. Mayer, MD (Other)

Overall Status

Terminated

CT.gov ID

NCT01602822

Collaborator

Bristol-Myers Squibb (Industry), Gilead Sciences (Industry), Abbott (Industry)

Enrollment

Location

Arm

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

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 :

Feb 1, 2012

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Primary Outcome Measures

Safety of regimen [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 [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

Awareness of NPEP [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.