HIV Non Occupational Post-Exposure Prophylaxis (PEP)

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fenway Community Health
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Tenofovir

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.