Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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. This is what is called a phase II clinical trial, only recruiting and following a small number of children (50) during one year to evaluate the quantity of drug in the blood just before it is taken and one to three hours after it is taken. The other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Didanosine; Efavirenz; Lamivudine

Criteria

Inclusion Criteria:

• 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 Criteria:

• HIV-2 or dual HIV infection

• Previous antiretroviral therapy

• Children unable to swallow pills

• Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)