Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age
NCT ID: NCT01127204
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
161 participants
INTERVENTIONAL
2011-06-30
2015-04-30
Brief Summary
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The perspective of this project is to identify antiretroviral strategies to improve treatment access and adherence for children in sub-saharian Africa.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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arm 1 (reference strategy)
AZT-3TC-LPV/r twice a day
AZT-3TC-LPV/r twice a day
AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily
arm 2 (simplification strategy)
ABC-3TC-EFV once a day
ABC-3TC-EFV once a day
ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake
Interventions
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AZT-3TC-LPV/r twice a day
AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily
ABC-3TC-EFV once a day
ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake
Eligibility Criteria
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Inclusion Criteria
* HIV-1 infection diagnose by RT PCR after 6 weeks of life
* age between 3 and 12 month at the antiretroviral treatment initiation
* naive of antiretrovirals except if received for the prevention of mother to child HIV transmission
* HB\>=7 g/dl, neutrophiles\>750/mm3, creatinin\<3xULN, TGO and TGP\<3xULN
* signed informed consent
* age 24 months at most
* virological success define as 2 consecutive indetectable HIV RNA measured by RT PCR at least 3 months apart.
Exclusion Criteria
* Known intolerance to one of the trial treatment
* HB\<7 g/dl, neutrophiles\<750/mm3, creatinin\>3xULN, TGO or TGP\>3xULN
* virological failure after the first 12 months of antiretroviral treatment
3 Months
12 Months
ALL
No
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Public Research Centre Health, Luxembourg
OTHER
Ministry of Foreign Affairs, Luxembourg
UNKNOWN
University of Ouagadougou, Burkina Faso
OTHER
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
OTHER
Ministry of Health, Rwanda
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University of Bordeaux
OTHER
Institut de Sante Publique, d'Epidémiologie et de Développement
UNKNOWN
Université Montpellier
OTHER
University of Paris 5 - Rene Descartes
OTHER
Queen Fabiola Children's University Hospital
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Marguerite Timite-Konan
Role: PRINCIPAL_INVESTIGATOR
Service de pédiatrie - CHU Yopougon - Abidjan, Côte d'Ivoire
Jules Mugabo
Role: PRINCIPAL_INVESTIGATOR
Center for Infectious Desease Control - Kigali, Rwanda
Nicolas Meda
Role: PRINCIPAL_INVESTIGATOR
Université de Ouagadougou - Ouagadougou, Burkina Faso
Locations
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Service de maladies infectieuses - CHU Charles de Gaulle
Ouagadougou, , Burkina Faso
Service de pédiatrie - CHU Yalgado Ouedraogo
Ouagadougou, , Burkina Faso
CEPREF
Abidjan, , Côte d’Ivoire
FSU abobo-Avocatier
Abidjan, , Côte d’Ivoire
Countries
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References
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Pressiat C, Toni TD, Treluyer JM, Yonaba C, Dahourou DL, Malateste K, Seguin-Devaux C, Leroy V, Hirt D; MONOD ANRS Study Group. High nevirapine levels in breast milk and consequences in HIV-infected child when initiated on antiretroviral therapy. AIDS. 2021 Nov 15;35(14):2409-2410. doi: 10.1097/QAD.0000000000003043. No abstract available.
Desmonde S, Frank SC, Coovadia A, Dahourou DL, Hou T, Abrams EJ, Amorissani-Folquet M, Walensky RP, Strehlau R, Penazzato M, Freedberg KA, Kuhn L, Leroy V, Ciaranello AL. Cost-Effectiveness of Preemptive Switching to Efavirenz-Based Antiretroviral Therapy for Children With Human Immunodeficiency Virus. Open Forum Infect Dis. 2019 Jun 11;6(7):ofz276. doi: 10.1093/ofid/ofz276. eCollection 2019 Jul.
Pressiat C, Mea-Assande V, Yonaba C, Treluyer JM, Dahourou DL, Amorissani-Folquet M, Blanche S, Eboua F, Ye D, Lui G, Malateste K, Zheng Y, Leroy V, Hirt D; MONOD Study Group. Suboptimal cotrimoxazole prophylactic concentrations in HIV-infected children according to the WHO guidelines. Br J Clin Pharmacol. 2017 Dec;83(12):2729-2740. doi: 10.1111/bcp.13397. Epub 2017 Sep 20.
Pressiat C, Amorissani-Folquet M, Yonaba C, Treluyer JM, Dahourou DL, Eboua F, Blanche S, Mea-Assande V, Bouazza N, Foissac F, Malateste K, Ouedraogo S, Lui G, Leroy V, Hirt D. Pharmacokinetics of Efavirenz at a High Dose of 25 Milligrams per Kilogram per Day in Children 2 to 3 Years Old. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00297-17. doi: 10.1128/AAC.00297-17. Print 2017 Jul.
Amani-Bosse C, Dahourou DL, Malateste K, Amorissani-Folquet M, Coulibaly M, Dattez S, Emieme A, Barry M, Rouzioux C, N'gbeche S, Yonaba C, Timite-Konan M, Mea V, Ouedraogo S, Blanche S, Meda N, Seguin-Devaux C, Leroy V. Virological response and resistances over 12 months among HIV-infected children less than two years receiving first-line lopinavir/ritonavir-based antiretroviral therapy in Cote d'Ivoire and Burkina Faso: the MONOD ANRS 12206 cohort. J Int AIDS Soc. 2017 Apr 25;20(1):21362. doi: 10.7448/IAS.20.01.21362.
Dahourou DL, Amorissani-Folquet M, Malateste K, Amani-Bosse C, Coulibaly M, Seguin-Devaux C, Toni T, Ouedraogo R, Blanche S, Yonaba C, Eboua F, Lepage P, Avit D, Ouedraogo S, Van de Perre P, N'Gbeche S, Kalmogho A, Salamon R, Meda N, Timite-Konan M, Leroy V; MONOD Study Group. Efavirenz-based simplification after successful early lopinavir-boosted-ritonavir-based therapy in HIV-infected children in Burkina Faso and Cote d'Ivoire: the MONOD ANRS 12206 non-inferiority randomised trial. BMC Med. 2017 Apr 24;15(1):85. doi: 10.1186/s12916-017-0842-4.
Dahourou DL, Amorissani-Folquet M, Coulibaly M, Avit-Edi D, Meda N, Timite-Konan M, Arendt V, Ye D, Amani-Bosse C, Salamon R, Lepage P, Leroy V; Monod Anrs 12206 Study Group. Missed opportunities of inclusion in a cohort of HIV-infected children to initiate antiretroviral treatment before the age of two in West Africa, 2011 to 2013. J Int AIDS Soc. 2016 Mar 23;19(1):20601. doi: 10.7448/IAS.19.1.20601. eCollection 2016.
Other Identifiers
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IP.2007.33011.002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANRS 12206 MONOD
Identifier Type: -
Identifier Source: org_study_id
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