NCT01114425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

April 28, 2010

Last Update Submit

February 22, 2017

Conditions

HIV Infections

Keywords

tolerability of post exposure to HIV infection prophylaxis

Outcome Measures

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.

    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.

    one year

Interventions

raltegravir (Isentress)DRUG

raltegravir (Isentress) 400 mg bid

Truvada®DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GERES

Paris, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir PotassiumEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Christian RABAUD, MD., PhD.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 3, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

FR(1)