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

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ClinicalTrials.gov Identifier: NCT00122538
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : December 5, 2011
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Tracking Information
First Submitted Date  ICMJE July 19, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date December 5, 2011
Study Start Date  ICMJE February 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
  • 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 ]
  • Cmin and Cmax for the three drugs [ Time Frame: 15 days ]
  • Grade 3 or 4 undesirable effects frequency [ Time Frame: through out the trial ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
  • Percentage of patients with CD4 greater than 25 percent at M12 and M24 [ Time Frame: 12 and 24 months ]
  • Amplitude of viral load reduction [ Time Frame: 12 and 24 months ]
  • Slope of CD4 compared with the initial values [ Time Frame: 12 and 24 months ]
  • Percentage of patients lost to follow-up [ Time Frame: 12 and 24 months ]
  • Percentage of deaths and of B or C classing events [ Time Frame: Through out the trial ]
  • Percentage of treatment interruption [ Time Frame: Through out the trial ]
  • Percentage and type of resistance mutations [ Time Frame: 12 and 24 months ]
  • Percentage of patients forgetting more than one pill within the last three days [ Time Frame: Through out the trial ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • 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 resistance mutations
  • Percentage of patients forgetting more than one pill within the last three days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
Official Title  ICMJE HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • AIDS
Intervention  ICMJE
  • Drug: Efavirenz (EFV)
  • Drug: Lamivudine (3TC)
  • Drug: Didanosine (ddI)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2008)
52
Original Enrollment  ICMJE
 (submitted: July 19, 2005)
50
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122538
Other Study ID Numbers  ICMJE ANRS 12103 BURKINAME
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Agency for Research on AIDS and Viral Hepatitis
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account French National Agency for Research on AIDS and Viral Hepatitis
Verification Date December 2011

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