Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Gilead Sciences; Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Tenofovir

Criteria

Inclusion Criteria:

• Patients must be at least 18 years of age

• HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection

• Able to understand and provide consent

• High-Risk Exposure Characteristic (One or more of the below, unprotected or with failed condom use):

• Receptive Anal Intercourse

• Insertive Anal Intercourse

• Receptive Vaginal Intercourse

• Insertive Vaginal Intercourse

• Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source

• High-Risk Source (One or more of the below):

• Known HIV positive

• MSM

• MSM/W

• CSW

• Sexual perpetrator Partner of one of the above

• Exposure within 72 hours of presentation

• Not known to be HIV-1 positive

• No countermanding concomitant medications or allergies

Exclusion Criteria:

• Patients <18 years of age

• Unable to understand and provide consent

• Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure

• Known to be HIV positive

• Any condition which in the opinion of the intake provider will seriously compromise the patient's ability to comply with the protocol, including adherence to nPEP medication

• Demonstrated HIV-1 positive on rapid testing

• Unwillingness to commit to barrier-method (male and/or female condom) use until HIV negative status is confirmed 6 months after exposure

• Unwillingness of breast-feeding women to transition to formula feeding

• 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 or other therapy for hepatitis B

• Creatinine clearance less than 30 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