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

HIV Clinical Trial

— BMS PEP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602822
• Other study ID #: BMS PEP
• Status: Terminated
• Phase: Phase 4
• First received: February 8, 2012
• Last updated: March 6, 2013
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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
• Ritonavir, Atazanavir, Truvada

Locations

Country	Name	City	State
United States	Fenway Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Kenneth H. Mayer, MD	Abbott, Bristol-Myers Squibb, Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of regimen	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.).	Visit 3- Day 30
Primary	Tolerability of regimen	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.).	Visit 3- Day 30
Secondary	Awareness of NPEP	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).	Visit 5- Day 170
Secondary	Compare adherence rates	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). ?2 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)	Visit 3- Day 30

External Links

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