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Completed

NCT Number: NCT00122538

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

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.

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Key information

Conditions

HIV Infections AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

30 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de pediatrie, CHU Sanou Souro

Bobo-Dioulasso, 01 BP 676, Burkina Faso

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Efavirenz (EFV)

Drug

Lamivudine (3TC)

Drug

Didanosine (ddI)

Drug

Primary outcomes

  1. 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

  2. Cmin and Cmax for the three drugs

    Time frame: 15 days

  3. Grade 3 or 4 undesirable effects frequency

    Time frame: through out the trial

Secondary outcomes

  1. Percentage of patients with CD4 greater than 25 percent at M12 and M24

    Time frame: 12 and 24 months

  2. Amplitude of viral load reduction

    Time frame: 12 and 24 months

  3. Slope of CD4 compared with the initial values

    Time frame: 12 and 24 months

  4. Percentage of patients lost to follow-up

    Time frame: 12 and 24 months

  5. Percentage of deaths and of B or C classing events

    Time frame: Through out the trial

  6. Percentage of treatment interruption

    Time frame: Through out the trial

  7. Percentage and type of resistance mutations

    Time frame: 12 and 24 months

  8. Percentage of patients forgetting more than one pill within the last three days

    Time frame: Through out the trial

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Registry information

Official study title

HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jul 22, 2005
Registry last updated
Dec 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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