Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)
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ClinicalTrials.gov Identifier: NCT00122538 |
Recruitment Status
:
Completed
First Posted
: July 22, 2005
Last Update Posted
: December 5, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections AIDS | Drug: Efavirenz (EFV) Drug: Lamivudine (3TC) Drug: Didanosine (ddI) | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | May 2009 |

- 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 ]
- Cmin and Cmax for the three drugs [ Time Frame: 15 days ]
- Grade 3 or 4 undesirable effects frequency [ Time Frame: through out the trial ]
- Percentage of patients with CD4 greater than 25 percent at M12 and M24 [ Time Frame: 12 and 24 months ]
- Amplitude of viral load reduction [ Time Frame: 12 and 24 months ]
- Slope of CD4 compared with the initial values [ Time Frame: 12 and 24 months ]
- Percentage of patients lost to follow-up [ Time Frame: 12 and 24 months ]
- Percentage of deaths and of B or C classing events [ Time Frame: Through out the trial ]
- Percentage of treatment interruption [ Time Frame: Through out the trial ]
- Percentage and type of resistance mutations [ Time Frame: 12 and 24 months ]
- Percentage of patients forgetting more than one pill within the last three days [ Time Frame: Through out the trial ]

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Ages Eligible for Study: | 30 Months to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122538
Burkina Faso | |
Service de pediatrie, CHU Sanou Souro | |
Bobo-Dioulasso, Burkina Faso, 01 BP 676 |
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 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 |
First Posted: | July 22, 2005 Key Record Dates |
Last Update Posted: | December 5, 2011 |
Last Verified: | December 2011 |
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:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Efavirenz Didanosine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antimetabolites |