Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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.


NCT ID:

NCT00594646


Primary Contact:

Principal Investigator
Kenneth H Mayer, MD
Fenway Community Health


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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