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:
Kenneth H. Mayer, MD
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
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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
Tenofovir Disoproxil Fumarate
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 (Adult, Senior) |
| 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
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:
| 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:
|
Ritonavir Atazanavir Sulfate Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016