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

Completed · Phase 4

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01214759

Run by

The University of Texas Health Science Center, Houston

People needed

103

Starts

2011-05-01

Expected to finish

2015-08-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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