HIV Infections, AIDS
Conditions
Keywords
HAART, once-daily, child, africa, HIV, AIDS, Treatment Naive
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. 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.
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 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).
Interventions
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Months to 15 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12) | 12 and 24 months |
| Cmin and Cmax for the three drugs | 15 days |
| Grade 3 or 4 undesirable effects frequency | through out the trial |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients lost to follow-up | 12 and 24 months |
| Percentage of deaths and of B or C classing events | Through out the trial |
| Percentage of patients with CD4 greater than 25 percent at M12 and M24 | 12 and 24 months |
| Percentage and type of resistance mutations | 12 and 24 months |
| Percentage of patients forgetting more than one pill within the last three days | Through out the trial |
| Percentage of treatment interruption | Through out the trial |
| Amplitude of viral load reduction | 12 and 24 months |
| Slope of CD4 compared with the initial values | 12 and 24 months |
Countries
Burkina Faso
Outcome results
None listed