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
  Purpose

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.


Condition Intervention Phase
HIV Infections
AIDS
Drug: Efavirenz (EFV)
Drug: Lamivudine (3TC)
Drug: Didanosine (ddI)
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: February 2006
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   30 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122538

Locations
Burkina Faso
Service de pediatrie, CHU Sanou Souro
Bobo-Dioulasso, Burkina Faso, 01 BP 676
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
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
  More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00122538     History of Changes
Other Study ID Numbers: ANRS 12103 BURKINAME
Study First Received: July 19, 2005
Last Updated: December 2, 2011
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HAART
once-daily
child
africa
HIV
AIDS
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Didanosine
Lamivudine
Efavirenz
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014