Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
ClinicalTrials.gov Identifier:
NCT01114425
First received: April 28, 2010
Last updated: April 30, 2010
Last verified: April 2010
  Purpose

The objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, Truvada® [0-0-1] + Isentress® 400 mg tablets [1-0-1], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of HIV infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.


Condition Intervention Phase
HIV Infections
Drug: raltegravir (Isentress)
Drug: Truvada®
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux:

Primary Outcome Measures:
  • To assess the nature and incidence of drug intolerance and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals. [ Time Frame: one year ] [ Designated as safety issue: No ]

    Proportion of patients who stop the post-exposure treatment before the planned 28 days, owing to adverse reaction(s).

    Proportion of patients reporting a post-exposure treatment-related side effect before the end of the treatment.



Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: raltegravir (Isentress)
    raltegravir (Isentress) 400 mg bid
    Drug: Truvada®
  Eligibility

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

Inclusion criteria

  • age 18 years or over
  • consultation immediately following exposure to the risk of transmission of HIV infection (less than 48 hours, except in the case of rape when this period may be increased to a maximum of 120 hours)
  • person capable of understanding the principle of the study and giving his/her informed consent

Exclusion criteria

  • subjects recently exposed to a risk of transmission of HIV infection in which the source patient is known to be infected with HIV and treated, and whose therapeutic history justifies the introduction of PET other than that proposed in this study
  • subjects with a contraindication to the prescription of Truvada® and/or Isentress® (renal impairment, allergy, etc.)
  • subjects previously treated with phenytoin, phenobarbital and rifampicin, since combination with raltegravir is contraindicated subjects known to be infected with hepatitis B virus, whether or not treated with lamivudine
  • subjects refusing to take part in the study
  • pregnant women
  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: NCT01114425

Locations
France
GERES Not yet recruiting
Paris, France
Contact: RABAUD       c.rabaud@chu-nancy.fr   
Sponsors and Collaborators
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Christian RABAUD, MD., PhD. Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
  More Information

No publications provided

Responsible Party: Christian RABAUD, GERES
ClinicalTrials.gov Identifier: NCT01114425     History of Changes
Other Study ID Numbers: 382426005_1
Study First Received: April 28, 2010
Last Updated: April 30, 2010
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux:
tolerability of post exposure to HIV infection prophylaxis

Additional relevant MeSH terms:
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 July 31, 2014