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| ID | Type | Description | Link |
|---|---|---|---|
| IP.2007.33011.002 | Other Grant/Funding Number | EDCTP |
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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
| Public Research Centre Health, Luxembourg | OTHER |
| Ministry of Foreign Affairs, Luxembourg | UNKNOWN |
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The MONOD trial aim to evaluate the implementation of early antiretroviral treatment strategies in HIV-infected infants and assess the feasibility and efficacy of simplifying the initial proposed regimen after a successful one year treatment. The initial treatment is AZT-3TC-LPV/r twice a day. After one year, the children will be randomized in one of the following : arm 1-reference AZT-3TC-LPV/r twice daily; arm 2-simplified ABC-3TC-EFV once daily.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 (reference strategy) | Active Comparator | AZT-3TC-LPV/r twice a day |
|
| arm 2 (simplification strategy) | Experimental | ABC-3TC-EFV once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZT-3TC-LPV/r twice a day | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial therapeutic cohort: Virological success | survival without virological failure (death or loss of follow-up or virologic failure, i.e. HIV-ARN ≥400 copies/mL on one consecutive sample), analysis of resistance profile. | 12 months |
| Randomised simplification phase: Virological success | survival without virological failure (death or loss of follow-up or virologic failure (HIV-ARN ≥400 copies/mL ))from M13 to M25. | 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Virological success | HIV RNA < 400 copies / mL | 12 months |
| Immunological response | CD4+ lymphocyte absolute count and percentage | 12 and 25 months |
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Inclusion Criteria for antiretroviral treatment initiation:
Exclusion Criteria for antiretroviral treatment initiation:
Inclusion Criteria for randomisation at 12 months in the simplification phase:
Exclusion Criteria for randomisation at 12 months in the simplification phase:
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| Name | Affiliation | Role |
|---|---|---|
| Marguerite Timite-Konan | Service de pédiatrie - CHU Yopougon - Abidjan, Côte d'Ivoire | Principal Investigator |
| Jules Mugabo | Center for Infectious Desease Control - Kigali, Rwanda | Principal Investigator |
| Nicolas Meda | Université de Ouagadougou - Ouagadougou, Burkina Faso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de maladies infectieuses - CHU Charles de Gaulle | Ouagadougou | Burkina Faso | ||||
| Service de pédiatrie - CHU Yalgado Ouedraogo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34723858 | Derived | 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. | |
| 31334298 |
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| 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 |
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| ABC-3TC-EFV once a day | Drug | 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 |
|
| Antiretroviral and cotrimoxazol pharmacokinetic parameters | The following parameters will be measured or calculated: maximal and minimal concentration (Cmax, Cmin), half life (t1/2), Aire Under the Curve (AUC), clearance and volume of distribution, for all antiretroviral (according to treatment arm : AZT, 3TC, LPV, ABC, EFV) and cotimoxazol. | 6, 19 and 25 months |
| Tolerance | occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrome | 12 and 25 month |
| Adherence | measurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success | 12 and 25 months |
| Resistance to antiretroviral | Genotyping to analyse resistance mutation when virological failure | 12 and 25 months |
| Ouagadougou |
| Burkina Faso |
| CEPREF | Abidjan | Côte d’Ivoire |
| FSU abobo-Avocatier | Abidjan | Côte d’Ivoire |
| 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. |
| 28800382 | Derived | 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. |
| 28483965 | Derived | 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. |
| 28453240 | Derived | 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. |
| 28434406 | Derived | 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. |
| 27015798 | Derived | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
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