Status:
COMPLETED
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
30-15 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to try a known antiretroviral combination in HIV- infected children with only one intake a day, in order to simplify the prescription and improve adherence to treatment. T...
Detailed Description
The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC + ddI + EFV have never been studied. This regimen may lead to a better treatment of the HIV-1 infected ch...
Eligibility Criteria
Inclusion
- HIV-1 infected children
- Weight over 12 kgs
- Age over 30 months
- Clinical stage requiring HAART
- Naive to antiretroviral treatment (except PMTCT prophylaxis)
- Mother's or tutor's informed consent signed
Exclusion
- HIV-2 or dual HIV infection
- Previous antiretroviral therapy
- Children unable to swallow pills
- Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00122538
Start Date
February 1 2006
End Date
May 1 2009
Last Update
December 5 2011
Active Locations (1)
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1
Service de pediatrie, CHU Sanou Souro
Bobo-Dioulasso, Burkina Faso, 01 BP 676