Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
3-6 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
Eligibility Criteria
Inclusion
- HIV-1 infected; \>=3 months of age to \<=6 years of age (at time of treatment); screening plasma viral load \>=1000 copies/mL
Exclusion
- Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00364793
Start Date
February 1 2007
End Date
July 1 2013
Last Update
April 29 2014
Active Locations (17)
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1
Local Institution
Buenos Aires, Buenos Aires, Argentina, 1425
2
Local Institution
Capital Federal, Argentina, 1425
3
Local Institution
Cali, Colombia
4
Local Institution
Colima, Colima, Mexico, 28019