Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
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.
Drug: Efavirenz (EFV)
Drug: Lamivudine (3TC)
Drug: Didanosine (ddI)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso|
- Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Cmin and Cmax for the three drugs [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- Grade 3 or 4 undesirable effects frequency [ Time Frame: through out the trial ] [ Designated as safety issue: Yes ]
- Percentage of patients with CD4 greater than 25 percent at M12 and M24 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Amplitude of viral load reduction [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Slope of CD4 compared with the initial values [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Percentage of patients lost to follow-up [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Percentage of deaths and of B or C classing events [ Time Frame: Through out the trial ] [ Designated as safety issue: Yes ]
- Percentage of treatment interruption [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
- Percentage and type of resistance mutations [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- Percentage of patients forgetting more than one pill within the last three days [ Time Frame: Through out the trial ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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 children in developing countries, as well as in Europe. Because of its simplicity it would facilitate observance that is one of the essential parameters of efficacy of treatments.
The main objectives are those of a phase II clinical trial:
- Assess the virological and immunological efficacy of a once daily HAART regimen comprising lamivudine (3TC) + didanosine (ddI) + efavirenz (EFV) [pediatric reference];
- Analyse the pharmacological characteristics of this combination in children;
- Assess the tolerance;
- Study the appearance of resistance;
Evaluate the observance to treatment.
50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage B or C) requires antiretroviral treatment, will be included in the study. They should be naive of any ARV treatment (except the treatment received in the framework of PMTCT (Prevention of Mother to Child Transmission).
Data Collection and Development of the Study:
- Monthly clinical examination;
- RNA HIV-1 and CD4 counts;
- Pharmacological dosages;
- Haematology and biochemistry surveillance;
- Genotypic resistance at inclusion; and, in case of unsuccess or failure,
- Assessment of observance according to alternate methods.
Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological tests sent to Montpellier Teaching Hospital (France).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122538
|Service de pediatrie, CHU Sanou Souro|
|Bobo-Dioulasso, Burkina Faso, 01 BP 676|
|Study Chair:||Philippe Msellati, MD, PhD||Institut de Recherche et de Développement (IRD UMR 145)|
|Principal Investigator:||Aboubacar Nacro, MD||CHU Sanou Souro, Bobo-Dioulasso|