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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir
* Drug: Ritonavir, Atazanavir, Truvada


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atazanavir, Ritonavir, Truvada<br>Open Label | Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir<br>* 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<br>Drug: Ritonavir, Atazanavir, Truvada<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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). 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) | Visit 3- Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, NPEP, PEP