HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT00594646
First received: January 7, 2008
Last updated: February 8, 2012
Last verified: February 2012

January 7, 2008
February 8, 2012
February 2008
March 2010   (final data collection date for primary outcome measure)
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: 4 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00594646 on ClinicalTrials.gov Archive Site
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: Day 0 and 4 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Drug: Fixed-dose Formulation of Tenofovir and Raletgravir
TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily and raltegravir, one 400mg tablet twice daily
Other Names:
  • Raltegravir(Mk-0518)
  • TRUVADA™ (emtricitabine and tenofovir disoproxil fumarate)
Not Provided
Not Provided

*   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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594646
MK PEP 2007
No
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
February 2012

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