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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.
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:
Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological tests sent to Montpellier Teaching Hospital (France).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz (EFV) | Drug | |||
| Lamivudine (3TC) | Drug | |||
| Didanosine (ddI) | Drug |
| Measure | Description | 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) | 12 and 24 months | |
| Cmin and Cmax for the three drugs | 15 days | |
| Grade 3 or 4 undesirable effects frequency | through out the trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de pediatrie, CHU Sanou Souro | Bobo-Dioulasso | 01 BP 676 | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23719348 | Derived | 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. | |
| 21857286 | Derived |
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| 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 |
| Percentage of treatment interruption | Through out the trial |
| Percentage and type of resistance mutations | 12 and 24 months |
| Percentage of patients forgetting more than one pill within the last three days | Through out the trial |
| 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. |
| 20516271 | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| D019259 | Lamivudine |
| D016049 | Didanosine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
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