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

NCT01214759 | Completed Phase 4 Results DMC

• 1 other identifier: UT-NPEP
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; prevention; prophylaxis; Raltegravir; Truvada

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study

  28 days

• 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

Study Arms (1)

Truvada and Raltegravir

OTHER

Single arm

Drug: Truvada; Drug: Raltegravir

Interventions

Truvada DRUG

Tenofovir 200mg/emtricitabine 300mg once a day

Also known as: Tenofovir 200mg/emtricitabine 300mg

Truvada and Raltegravir

Raltegravir DRUG

Raltegravir 400mg twice a day

Also known as: Isentress

Truvada and Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Merck Sharp & Dohme LLC: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (4)

• 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.

  PMID: 15660015 BACKGROUND

• 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.

  PMID: 15577628 BACKGROUND

• 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.

  PMID: 11181146 BACKGROUND

• 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.

  PMID: 7502044 BACKGROUND

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Pyrrolidinones; Pyrrolidines

Limitations and Caveats

This is a pilot study with a small sample size.

Results Point of Contact

• Title: Dr. Karen Vigil
• Organization: The University of Texas Health Science Center at Houston

Karen.J.Vigil@uth.tmc.edu

(713) 500-6703

Study Officials

• Karen J Vigil, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Internal Medicine

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 5, 2010
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2015
• Last Updated: February 8, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-01

Locations

US (1)