Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122538
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2005-07-19
Brief Title:
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso ANRS 12103 BURKINAME
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
HAART Regimen Comprising 3TC ddI EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None