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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122538
First received: July 19, 2005
Last updated: December 2, 2011
Last verified: December 2011

July 19, 2005
December 2, 2011
February 2006
November 2008   (final data collection date for primary outcome measure)
  • 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 HIV RNA less than 400 copies per ml and less than 50 copies per ml at M12
  • Cmin and Cmax for the three drugs
  • Grade 3 or 4 undesirable effects frequency
Complete list of historical versions of study NCT00122538 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patient with CD4 over 25 percent at M12
  • Amplitude of Viral load reduction
  • Slope of CD4 compared with the initial values
  • Percentage of patients lost of follow up
  • Percentage of deaths and of B or C classing events
  • Percentage of treatment interruption
  • Percentage and type of resistances mutations
  • Percentage of patients forgetting more than one pill within the last three days
Not Provided
Not Provided
 
Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso

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.

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).

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
  • Drug: Efavirenz (EFV)
  • Drug: Lamivudine (3TC)
  • Drug: Didanosine (ddI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
May 2009
November 2008   (final data collection date for primary outcome measure)

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)
Both
30 Months to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT00122538
ANRS 12103 BURKINAME
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
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
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP