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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01114425

Enrollment

149

Registered

2010-05-03

Start date

2010-11-01

Completion date

2012-12-01

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

tolerability of post exposure to HIV infection prophylaxis

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.

Interventions

DRUGraltegravir (Isentress)

raltegravir (Isentress) 400 mg bid

DRUGTruvada®

Study design

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026