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

December 2, 2011 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso, 01 BP 676
        • Service de pediatrie, CHU Sanou Souro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 and 24 months
Cmin and Cmax for the three drugs
Time Frame: 15 days
15 days
Grade 3 or 4 undesirable effects frequency
Time Frame: through out the trial
through out the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with CD4 greater than 25 percent at M12 and M24
Time Frame: 12 and 24 months
12 and 24 months
Amplitude of viral load reduction
Time Frame: 12 and 24 months
12 and 24 months
Slope of CD4 compared with the initial values
Time Frame: 12 and 24 months
12 and 24 months
Percentage of patients lost to follow-up
Time Frame: 12 and 24 months
12 and 24 months
Percentage of deaths and of B or C classing events
Time Frame: Through out the trial
Through out the trial
Percentage of treatment interruption
Time Frame: Through out the trial
Through out the trial
Percentage and type of resistance mutations
Time Frame: 12 and 24 months
12 and 24 months
Percentage of patients forgetting more than one pill within the last three days
Time Frame: Through out the trial
Through out the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12103 BURKINAME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Lamivudine (3TC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe