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

NCT00122538 | Completed Phase 2 DMC

• 1 other identifier: ANRS 12103 BURKINAME
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; AIDS

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12)

  12 and 24 months

• Cmin and Cmax for the three drugs

  15 days

• Grade 3 or 4 undesirable effects frequency

  through out the trial

Secondary Outcomes (8)

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

  12 and 24 months

• Amplitude of viral load reduction

  12 and 24 months

• Slope of CD4 compared with the initial values

  12 and 24 months

• Percentage of patients lost to follow-up

  12 and 24 months

• Percentage of deaths and of B or C classing events

  Through out the trial

Interventions

Efavirenz (EFV) DRUG

Lamivudine (3TC) DRUG

Didanosine (ddI) DRUG

Eligibility Criteria

• Age: 30 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• HIV-2 or dual HIV infection
• Previous antiretroviral therapy
• Children unable to swallow pills
• Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service de pediatrie, CHU Sanou Souro

Bobo-Dioulasso, 01 BP 676, Burkina Faso

Location

Related Publications (3)

• 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.

  PMID: 23719348 DERIVED

• 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.

  PMID: 21857286 DERIVED

• 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.

  PMID: 20516271 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

efavirenz; Lamivudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Philippe Msellati, MD, PhD

  Institut de Recherche et de Développement (IRD UMR 145)

  STUDY CHAIR

• Aboubacar Nacro, MD

  CHU Sanou Souro, Bobo-Dioulasso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2005
• First Posted: July 22, 2005
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: December 5, 2011

Record last verified: 2011-12

Locations

BU (1)