Safety Study of Isentress® + Truvada® in Post-exposure Tr... | NCT01114425

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

NCT01114425

Sponsor

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

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

149Actual

Phase

Phase 3

Conditions

HIV Infections

Interventions

raltegravir (Isentress)
Truvada®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2010Actual

Primary Completion Date

Aug 1, 2012Actual

Completion Date

Dec 1, 2012Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

Apr 30, 2010

First Posted Date

May 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 23, 2017Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Name	Type	Description	Arm Group Labels	Other Names
raltegravir (Isentress)	Drug	raltegravir (Isentress) 400 mg bid
Truvada®	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian RABAUD, MD., PhD.	Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GERES		Paris			France

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068898	Raltegravir Potassium
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Ancestor Terms

ID	Term
D011760	Pyrrolidinones
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided