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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: Raltegravir; Drug: Truvada

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01214759

UT-NPEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

103 participants in 1 patient group

Truvada and Raltegravir

Other group

Description:

Single arm

Treatment:

Drug: Truvada

Drug: Raltegravir