Trial record 10 of 32 for:
" May 05, 2010":" June 04, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age
This study is currently recruiting participants.
Verified September 2012 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Public Research Centre Health, Luxembourg
Ministry of Foreign Affairs, Luxembourg
University of Ouagadougou, Burkina Faso
Programme national,ANRS,Coopération française-Côte d'Ivoire (PAC-CI), Côte d'Ivoire
Ministry of Health, Rwanda
Institut National de la Santé Et de la Recherche Médicale, France
University of Bordeaux
Institut de Sante Publique, d'Epidémiologie et de Développement
Université Montpellier
University of Paris 5 - Rene Descartes
Queen Fabiola Children's University Hospital
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01127204
First received: May 19, 2010
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: AZT-3TC-LPV/r twice a day Drug: ABC-3TC-EFV once a day |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase 3 Trial to Evaluate Two Simplified Antiretroviral Treatment Strategies in HIV Infected Children, Treated by Antiretroviral Triple Therapy Before One Year of Age, in Virological Success in Africa (Burkina Faso, Côte d'Ivoire, Rwanda) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Lamivudine
U.S. FDA Resources
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- Virological success [ Time Frame: 25 months ] [ Designated as safety issue: No ]HIV RNA < 50 copies / mL
Secondary Outcome Measures:
- Virological success [ Time Frame: 12 months ] [ Designated as safety issue: No ]HIV RNA < 400 copies / mL
- Immunological response [ Time Frame: 12 and 25 months ] [ Designated as safety issue: No ]CD4+ lymphocyte absolute count and percentage
- Antiretroviral and cotrimoxazol pharmacokinetic parameters [ Time Frame: 6, 19 and 25 months ] [ Designated as safety issue: No ]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.
- Tolerance [ Time Frame: 12 and 25 month ] [ Designated as safety issue: Yes ]occurence of grade 3 and 4 adverse events related to the trial treatment, particularly occurence of immune reconstitution inflammatory syndrom
- Adherence [ Time Frame: 12 and 25 months ] [ Designated as safety issue: Yes ]measurement at each protocol visit of the three last days treatment intake to be corelated to the antiretroviral concentration and virological success
- Resistance to antiretroviral [ Time Frame: 12 and 25 months ] [ Designated as safety issue: Yes ]Genotyping to analyse resistance mutation when virological failure
| Estimated Enrollment: | 230 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: arm 1 (reference strategy)
AZT-3TC-LPV/r twice a day
|
Drug: 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
|
|
Experimental: arm 2 (simplification strategy)
ABC-3TC-EFV once a day
|
Drug: 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| Ages Eligible for Study: | 3 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria for antiretroviral treatment initiation:
- infant follow-up in one of the trial site
- 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
Exclusion Criteria for antiretroviral treatment initiation:
- HIV-2 infection or HIV-1/HIV-2 co-infection
- Known intolerance to one of the trial treatment
- HB<7 g/dl, neutrophiles<750/mm3, creatinin>3xULN, TGO or TGP>3xULN
Inclusion Criteria for randomisation at 12 months in the simplification phase:
- 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 for randomisation at 12 months in the simplification phase:
- virological failure after the first 12 months of antiretroviral treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127204
Contacts
| Contact: Valeriane Leroy | +33 (0)5 57 57 12 58 | valeriane.leroy@isped.u-bordeaux2.fr |
Locations
| Burkina Faso | |
| Service de pédiatrie - CHU Yalgado Ouedraogo | Recruiting |
| Ouagadougou, Burkina Faso | |
| Contact: Ludovic Kam, MD +226 70 17 72 17 prkaml@yahoo.fr | |
| Service de maladies infectieuses - CHU Charles de Gaulle | Recruiting |
| Ouagadougou, Burkina Faso | |
| Contact: Diara Yé, MD +226 50 36 6778 yediarra@hotmail.com | |
| Côte D'Ivoire | |
| CEPREF | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Eugène Messou, MD +225 07 01 50 11 messou_eugene@yahoo.fr | |
| FSU abobo-Avocatier | Recruiting |
| Abidjan, Côte D'Ivoire | |
| Contact: Gbaméné Kouassi, MD +225 05 67 93 72 dr_gbamkouassi@yahoo.fr | |
| Rwanda | |
| Centre Hospitalier de Kigali | Withdrawn |
| Kigali, Rwanda | |
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
European and Developing Countries Clinical Trials Partnership (EDCTP)
Public Research Centre Health, Luxembourg
Ministry of Foreign Affairs, Luxembourg
University of Ouagadougou, Burkina Faso
Programme national,ANRS,Coopération française-Côte d'Ivoire (PAC-CI), Côte d'Ivoire
Ministry of Health, Rwanda
Institut National de la Santé Et de la Recherche Médicale, France
University of Bordeaux
Institut de Sante Publique, d'Epidémiologie et de Développement
Université Montpellier
University of Paris 5 - Rene Descartes
Queen Fabiola Children's University Hospital
Investigators
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
| ClinicalTrials.gov Identifier: | NCT01127204 History of Changes |
| Other Study ID Numbers: | ANRS 12206 MONOD, IP.2007.33011.002 |
| Study First Received: | May 19, 2010 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Burkina Faso: Ministry of Health Cote d'Ivoire: Ministry of Health and Public Hygiene Rwanda: Ethics Committee |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
HIV Antiretroviral therapy Infant Sub Saharian Africa |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013