Clinical trial NCT01214759: Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Official title: A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: HIV
prevention
prophylaxis
Raltegravir
Truvada
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Gilead Sciences
First posted: 2010-10-05
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study
timeFrame: 28 days
measure: 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
timeFrame: 28 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Karen J Vigil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F, Struble KA, Cheever L, Johnson M, Paxton LA, Onorato IM, Greenberg AE; U.S. Department of Health and Human Services. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005 Jan 21;54(RR-2):1-20.
citation: Pinkerton SD, Martin JN, Roland ME, Katz MH, Coates TJ, Kahn JO. Cost-effectiveness of HIV postexposure prophylaxis following sexual or injection drug exposure in 96 metropolitan areas in the United States. AIDS. 2004 Oct 21;18(15):2065-73. doi: 10.1097/00002030-200410210-00011.
citation: Kahn JO, Martin JN, Roland ME, Bamberger JD, Chesney M, Chambers D, Franses K, Coates TJ, Katz MH. Feasibility of postexposure prophylaxis (PEP) against human immunodeficiency virus infection after sexual or injection drug use exposure: the San Francisco PEP Study. J Infect Dis. 2001 Mar 1;183(5):707-14. doi: 10.1086/318829. Epub 2001 Feb 1.
citation: Tsai CC, Follis KE, Sabo A, Beck TW, Grant RF, Bischofberger N, Benveniste RE, Black R. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl)adenine. Science. 1995 Nov 17;270(5239):1197-9. doi: 10.1126/science.270.5239.1197.