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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Gilead Sciences
Information provided by (Responsible Party):
Karen Vigil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01214759
First received: September 30, 2010
Last updated: July 18, 2013
Last verified: July 2013

September 30, 2010
July 18, 2013
May 2011
December 2013   (final data collection date for primary outcome measure)
To determine the efficacy of the antiretroviral drugs being studies in this study to prevent the transmission of HIV infection to HIV negative people sexually exposed to HIV. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine if the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV negative people who have been exposed to HIV.
Same as current
Complete list of historical versions of study NCT01214759 on ClinicalTrials.gov Archive Site
  • To determine the clinical or laboratory abnormalities secondary to the 28-day exposure to the antiretroviral drugs being explore in this study to prevent the transmission of HIV infection. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • To determine the tolerability and capability to complete the 28-day course of the antiretroviral drugs being explore in this study to prevent the transmission of HIV infection. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
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)

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Drug: Tenofovir/emtricitabine and raltegravir
Tenofovir 200mg/emtricitabine 300mg once a day and Raltegravir 400mg twice a day
Other Names:
  • Truvada (Tenofovir 200mg/emtricitabine 300mg)
  • Isentress (Raltegravir 400mg)
Truvada and Raltegravir
Single arm
Intervention: Drug: Tenofovir/emtricitabine and raltegravir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
August 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01214759
UT-NPEP
Yes
Karen Vigil, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
  • Merck Sharp & Dohme Corp.
  • Gilead Sciences
Principal Investigator: Karen J Vigil, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP