A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection (PERIEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Projeto Praça Onze.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mauro Schechter, Projeto Praça Onze
ClinicalTrials.gov Identifier:
NCT01697046
First received: September 24, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

This will be a pilot, open label study involving 65 participants. All participants will be followed until seroconversion or until the last enrolled participant completes one year of follow-up, whichever happens first. Participant study number will be given at the screening visit, prior to inclusion in the study.

The chosen intervention and study regimen are based on the dynamics of viral infection and the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside and nucleotide analogues need to be phosphorylated intracellularly. On the other hand, available data indicate that it takes approximately 10 hours between exposure and HIV viral integration, offering a window of opportunity for Raltegravir to block integration and thus prevent infection, given that this drug does not need to be metabolized to exert its effect. The intervention will be maintained for 4 weeks following exposure, in accordance with Brazilian and CDC guidelines for PEP.


Condition Intervention Phase
Infection
HIV
Drug: Truvada and Isentress
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of the Safety, Acceptability, Behavior Impact, and HIV Seroincidence Among High Risk Men Who Have Sex With Men With Access to Isentress 400 mg BID + Truvada Once Daily for Peri-exposure Chemoprophylaxis for HIV Infection Chemoprophylaxis for HIV Infection

Resource links provided by NLM:


Further study details as provided by Projeto Praça Onze:

Primary Outcome Measures:
  • Safety [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
    Number and severity of adverse events


Secondary Outcome Measures:
  • HIV seroincidence [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    Rate of incidence of new infections


Estimated Enrollment: 65
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isentress+Truvada
All participants will receive the intervention
Drug: Truvada and Isentress

Subjects with reported high-risk behavior (and anticipated future high-risk behavior) but no exposure in the immediate past will be the focus of this study.

Participants will be prescribed raltegravir 400 mg BID + Truvada once daily. All study participants will receive a 4-days starter pack. Study participants will be instructed to start study drugs if they expect or experience an exposure of any mucous membrane (oral, urethral, anal) to semen. Subjects who expect or experience these exposures will be instructed to take 1 pill of Raltegravir 400mg and one pill of truvada, followed by a second dose of Raltegravir 12 hours later. From the second day onward, participants will be instructed to take Raltegravir 400 mg BID + Truvada once daily. The first dose should be taken no more than 6 hours before or 6 hours after the expected or actual exposure and continued for 28 days.


Detailed Description:

Subjects with reported high-risk behavior (and anticipated future high-risk behavior) but no exposure in the immediate past will be the focus of this study.

Participants will be prescribed raltegravir 400 mg BID + Truvada once daily. All study participants will receive a 4-days starter pack. Study participants will be instructed to start study drugs if they expect or experience an exposure of any mucous membrane (oral, urethral, anal) to semen. Subjects who expect or experience these exposures will be instructed to take 1 pill of Raltegravir 400mg and one pill of truvada, followed by a second dose of Raltegravir 12 hours later. From the second day onward, participants will be instructed to take Raltegravir 400 mg BID + Truvada once daily. The first dose should be taken no more than 6 hours before or 6 hours after the expected or actual exposure and continued for 28 days.

Enrolled subjects will also be instructed to report to the study site within 4 days of beginning study drugs to respond to a CASI questionnaire and to have blood taken. They will be instructed to return at the end of the 4-week chemoprophylaxis course for reevaluation and to be given another 4-day supply of medication. Under no circumstances will any participant be given a greater than 4 week supply of medication; all will be evaluated for toxicity and adherence following each course of chemoprophylaxis.

The study participants will be monitored closely for safety after each course of chemoprophylaxis and at the end of the trial. In addition, subjects will be instructed to immediately contact the site if they experience certain symptoms consistent with severe toxicity. At each evaluation a careful clinical history, physical examination, and laboratory assessment, including HIV serology, will be completed. Adherence will be estimated based on self-report and the use of pill counts. During each visit, subjects will be reminded of the need to not increase high-risk sexual behavior. HIV serology and response to a CASI questionnaire will be conducted monthly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals will be included in the clinical trial if they meet ALL of the following criteria:

  • Male sex (at birth);
  • Willing and able to provide written informed consent;
  • Age 18 years or older;
  • HIV-1-uninfected;
  • Absence of signs or symptoms compatible with an acute viral disease
  • Evidence of high risk for acquiring HIV-1 infection including any one of the following: 1) No condom use during the last receptive and/or insertive anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 4 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used.
  • Adequate renal function
  • Adequate hepatic function

Exclusion Criteria:

  • Glycosuria or proteinuria
  • Acute hepatitis B infection
  • History of pathological bone fractures not related to trauma
  • Active alcohol or drug use considered sufficient to hinder compliance with any study procedures
  • At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697046

Contacts
Contact: Monica Barbosa de Souza, BA +55 21 22739073 ext 14 monica@ponze.ufrj.br
Contact: Carina Beppu Yoshida, RN +55 21 22739073 ext 15 carina@ponze.ufrj.br

Locations
Brazil
Monica Barbosa de Souza Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20210-030
Contact: Carina Beppu Yoshida, RN    +55 21 22739073 ext 15    carina@ponze.ufrj.br   
Sub-Investigator: Rafael Quaresma Garrido, MD         
Sponsors and Collaborators
Projeto Praça Onze
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Mauro Schechter, MD, PhD Projeto Praça Onze
  More Information

Publications:
Responsible Party: Mauro Schechter, MD, PhD, Projeto Praça Onze
ClinicalTrials.gov Identifier: NCT01697046     History of Changes
Other Study ID Numbers: IIS# 39550
Study First Received: September 24, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency

Keywords provided by Projeto Praça Onze:
peri-exposure
chemoprophylaxis

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014