HIV Non Occupational Post-Exposure Prophylaxis (PEP)

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00594646

Run by

Fenway Community Health

People needed

100

Starts

2008-02-01

Expected to finish

2010-08-01

Last updated by the study team

2022-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fenway Community Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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