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
  Purpose

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: Fixed-dose Formulation of Tenofovir and Raletgravir
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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 7, 2008
Last Updated: February 8, 2012
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014