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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
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
History of Changes

April 28, 2010
April 30, 2010
September 2010
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01114425 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
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

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.
Not Provided
Interventional
Phase 3
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: raltegravir (Isentress)
    raltegravir (Isentress) 400 mg bid
  • Drug: Truvada®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
May 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Not Provided
France
 
NCT01114425
382426005_1
No
Christian RABAUD, GERES
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Merck
Principal Investigator: Christian RABAUD, MD., PhD. Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
April 2010

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