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HIV Non Occupational Post-Exposure Prophylaxis (PEP)

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ClinicalTrials.gov Identifier: NCT00594646
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: TRUVADA + raltegravir Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Group 1
TRUVADA + raltegravir
 Drug: TRUVADA + raltegravir
TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg
Other Names:
  • tenofovir DF
  • emtricitabine


Outcome Measures
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Primary Outcome Measures :
  1. Medication Regimen Completion Rates [ Time Frame: 28 days ]
    Pill counts performed at 14 and 28 days

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594646


Locations
United States, Massachusetts
Fenway Community Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Fenway Community Health
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Kenneth H Mayer, MD Fenway Community Health
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Link to full-text publication  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Kenneth H. Mayer, MD, Medical Director, The Fenway Institute, Fenway Community Health
ClinicalTrials.gov Identifier: NCT00594646     History of Changes
Other Study ID Numbers: MK PEP 2007
First Posted: January 16, 2008    Key Record Dates
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015
Last Verified: August 2015

Keywords provided by Kenneth H. Mayer, MD, Fenway Community Health:
HIV Prevention
Non-occupational post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Raltegravir Potassium
Emtricitabine
 Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors