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

Phase 4

Completed

Brief 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.

Detailed Description: Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen.

We aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Truvada and Raltegravir	Truvada	Single arm
Truvada and Raltegravir	Raltegravir	Single arm

Primary Outcome Measures

Name	Time	Method
Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months	6 months	This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study	28 days	Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.
Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study	28 days