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OpenTrials
Completed

NCT Number: NCT01114425

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GERES

Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

raltegravir (Isentress)

Drug

raltegravir (Isentress) 400 mg bid

Truvada®

Drug

Primary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Network

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 3, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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