HIV Non Occupational Post-Exposure Prophylaxis (PEP)

Fenway Community Health

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: TRUVADA + Raltegravir

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00594646

MK PEP 2007

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.