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HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594646
First Posted: January 16, 2008
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health
January 7, 2008
January 16, 2008
August 10, 2015
September 10, 2015
September 10, 2015
February 2008
March 2010   (Final data collection date for primary outcome measure)
  • Medication Regimen Completion Rates [ Time Frame: 28 days ]
    Pill counts performed at 14 and 28 days
  • Number of HIV-1 Infected Participants [ Time Frame: 90 days ]
    Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected
Evaluate the safety and tolerability of a regimen containing TDF/FTC once daily and raltegravir when given for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. [ Time Frame: Visit 5 ]
Complete list of historical versions of study NCT00594646 on ClinicalTrials.gov Archive Site
Not Provided
To describe awareness and attitudes around NPEP among persons presenting for NPEP after a high-risk sexual contact, both at study entry and after completion of NPEP. [ Time Frame: Study Completion ]
Not Provided
Not Provided
 
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
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
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
  • tenofovir DF
  • emtricitabine
Group 1
TRUVADA + raltegravir
Intervention: Drug: TRUVADA + raltegravir
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00594646
MK PEP 2007
No
Not Provided
Not Provided
Kenneth H. Mayer, MD, Fenway Community Health
Fenway Community Health
Merck Sharp & Dohme Corp.
Principal Investigator: Kenneth H Mayer, MD Fenway Community Health
Fenway Community Health
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP