Back to resultsHIV Non Occupational Post-Exposure Prophylaxis (PEP)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TRUVADA + Raltegravir
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention, Non-occupational post-exposure prophylaxis, HIV seronegativity
Eligibility Criteria
Inclusion Criteria:
- HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
- 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.
- Able to understand the study procedures and willing to sign informed consent
Exclusion Criteria:
- Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
- Pregnancy.
- Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
- Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
- Unwillingness to participate in study procedures, including Mental Health referral and intervention.
- Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
- Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
Sites / Locations
- Fenway Community Health
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group 1
Arm Description
TRUVADA
Outcomes
Primary Outcome Measures
Medication Regimen Completion Rates
Pill counts performed at 14 and 28 days
Number of HIV-1 Infected Participants
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Secondary Outcome Measures
Full Information
NCT ID
NCT00594646
First Posted
January 7, 2008
Last Updated
October 4, 2022
Sponsor
Fenway Community Health
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00594646
Brief Title
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
Official Title
A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fenway Community Health
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
This study will evaluate a three drug regimen in the form of two pills which will be taken for 28 days for the prevention of HIV infection. Two drugs are combined in an FDA-approved pill called TRUVADA, containing the HIV medications, tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, taken as one pill once a day. The third drug is a new formulation, raltegravir 400mg pill taken twice a day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention, Non-occupational post-exposure prophylaxis, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
TRUVADA
Intervention Type
Drug
Intervention Name(s)
TRUVADA + Raltegravir
Other Intervention Name(s)
tenofovir DF, emtricitabine
Intervention Description
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Primary Outcome Measure Information:
Title
Medication Regimen Completion Rates
Description
Pill counts performed at 14 and 28 days
Time Frame
28 days
Title
Number of HIV-1 Infected Participants
Description
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
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.
Able to understand the study procedures and willing to sign informed consent
Exclusion Criteria:
Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
Pregnancy.
Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
Unwillingness to participate in study procedures, including Mental Health referral and intervention.
Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth H Mayer, MD
Organizational Affiliation
Fenway Community Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fenway Community Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22267017
Citation
Mayer KH, Mimiaga MJ, Gelman M, Grasso C. Raltegravir, tenofovir DF, and emtricitabine for postexposure prophylaxis to prevent the sexual transmission of HIV: safety, tolerability, and adherence. J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):354-9. doi: 10.1097/QAI.0b013e31824a03b8.
Results Reference
result
Links:
URL
http://journals.lww.com/jaids/Fulltext/2012/04010/Raltegravir,_Tenofovir_DF,_and_Emtricitabine_for.6.aspx
Description
Link to full-text publication
Learn more about this trial
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
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