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

HIV Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214759
• Other study ID #: UT-NPEP
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2010
• Last updated: January 7, 2016
• Start date: May 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

Drug:
• Truvada
Tenofovir 200mg/emtricitabine 300mg once a day
• Raltegravir
Raltegravir 400mg twice a day

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Gilead Sciences, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Epub 2001 Feb 1. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 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.	6 months	No
Secondary	Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study	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.	28 days	Yes
Secondary	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	No