Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
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|ClinicalTrials.gov Identifier: NCT01114425|
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: raltegravir (Isentress) Drug: Truvada®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 1, 2010|
|Actual Primary Completion Date :||August 1, 2012|
|Actual Study Completion Date :||December 1, 2012|
Drug: raltegravir (Isentress)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114425
|Principal Investigator:||Christian RABAUD, MD., PhD.||Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux|