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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

raltegravir (Isentress)

Truvada®

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring tolerability of post exposure to HIV infection prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GERES

Outcomes

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01114425

First Posted

April 28, 2010

Last Updated

February 22, 2017

Sponsor

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

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01114425

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2010 (Actual)

Primary Completion Date

August 1, 2012 (Actual)

Study Completion Date

December 1, 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

tolerability of post exposure to HIV infection prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

raltegravir (Isentress)

Intervention Description

raltegravir (Isentress) 400 mg bid

Intervention Type

Drug

Intervention Name(s)

Truvada®

Primary Outcome Measure Information:

Title

Description

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian RABAUD, MD., PhD.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

GERES

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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