Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection
Phase 3
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT01114425
- Lead Sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GERES
🇫🇷Paris, France