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

NCT ID: NCT00122538

Last Updated: 2011-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-05-31

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).

Conditions

HIV Infections; AIDS

Keywords

HAART; once-daily; child; africa; HIV; AIDS; Treatment Naive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Efavirenz (EFV)

Intervention Type: DRUG

Lamivudine (3TC)

Intervention Type: DRUG

Didanosine (ddI)

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Msellati, MD, PhD

Role: STUDY_CHAIR

Institut de Recherche et de Développement (IRD UMR 145)

Aboubacar Nacro, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Sanou Souro, Bobo-Dioulasso

Locations

Service de pediatrie, CHU Sanou Souro

Bobo-Dioulasso, , Burkina Faso

Countries

Burkina Faso

References

Bouazza N, Treluyer JM, Msellati P, Van de Perre P, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Hirt D, Urien S. A novel pharmacokinetic approach to predict virologic failure in HIV-1-infected paediatric patients. AIDS. 2013 Mar 13;27(5):761-8. doi: 10.1097/QAD.0b013e32835caad1.

Reference Type: DERIVED

PMID: 23719348 (View on PubMed)

Barro M, Some J, Foulongne V, Diasso Y, Zoure E, Hien H, Francois R, Michel S, Drabo A, Tamboura H, Ouiminga A, Diagbouga S, Hien A, Yameogo S, Van De Perre P, Nacro B, Msellati P. Short-term virological efficacy, immune reconstitution, tolerance, and adherence of once-daily dosing of didanosine, lamivudine, and efavirenz in HIV-1-infected African children: ANRS 12103 Burkiname. J Acquir Immune Defic Syndr. 2011 Jul 1;57 Suppl 1:S44-9. doi: 10.1097/QAI.0b013e31821fd64f.

Reference Type: DERIVED

PMID: 21857286 (View on PubMed)

Bouazza N, Hirt D, Bardin C, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Van De Perre P, Treluyer JM, Msellati P, Urien S. Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children? Antimicrob Agents Chemother. 2010 Aug;54(8):3280-6. doi: 10.1128/AAC.00306-10. Epub 2010 Jun 1.

Reference Type: DERIVED

PMID: 20516271 (View on PubMed)

Other Identifiers

ANRS 12103 BURKINAME

Identifier Type: -

Identifier Source: org_study_id