HIV Non Occupational Post-Exposure Prophylaxis (PEP)

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health Identifier:
First received: January 7, 2008
Last updated: August 10, 2015
Last verified: August 2015
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 Infections
Drug: TRUVADA + raltegravir
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 Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1

Resource links provided by NLM:

Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • Medication Regimen Completion Rates [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Pill counts performed at 14 and 28 days

  • Number of HIV-1 Infected Participants [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
TRUVADA + raltegravir
Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
  • tenofovir DF
  • emtricitabine

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  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 identifier: NCT00594646

United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Fenway Community Health
Merck Sharp & Dohme Corp.
Principal Investigator: Kenneth H Mayer, MD Fenway Community Health
  More Information

Additional Information:
Responsible Party: Kenneth H. Mayer, MD, Medical Director, The Fenway Institute, Fenway Community Health Identifier: NCT00594646     History of Changes
Other Study ID Numbers: MK PEP 2007 
Study First Received: January 7, 2008
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Fenway Community Health:
HIV Prevention
Non-occupational post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 23, 2016