Children Infected by HIV Clinical Trial
— EPFOfficial title:
ANRS CO10 EPF - Cohort of HIV-infected Children
| NCT number | NCT03235258 |
| Other study ID # | ANRS CO10 EPF |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2004 |
| Est. completion date | June 2020 |
| Verified date | April 2021 |
| Source | ANRS, Emerging Infectious Diseases |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to describe the conditions of access to early treatment of children infected with HIV, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions
| Status | Completed |
| Enrollment | 812 |
| Est. completion date | June 2020 |
| Est. primary completion date | June 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 13 Years |
| Eligibility | Inclusion Criteria: - HIV-infected children born to mothers included in ANRS-CO1 EPF or children under the age of 13 newly entered in care management with no prior antiretroviral therapy, whose mother was or not included in ANRS-CO1 EPF Exclusion Criteria: - >= 13 years - refusal of legal representative of the child - antiretroviral therapy started before the entry in care management - care management for over 6 months before inclusion |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Angers | Angers | |
| France | CHU Hôpital Jean Minjoz | Besancon | |
| France | Hôpital Jean Verdier | Bondy | |
| France | Centre Hospitalier Pellegrin | Bordeaux | |
| France | CHU Caen | Caen | |
| France | Hôpital Antoine Béclère | Clamart | |
| France | Hôpital Louis Mourier | Colombes | |
| France | Centre hospitalier Francilien Sud | Corbeil-Essonnes | |
| France | Hôpital Bicêtre | Le Kremlin Bicëtre | |
| France | CHR Jeanne de Flandres | Lille | |
| France | Institut d'Hématologie et Oncologie Pédiatrique | Lyon | |
| France | CHR Arnaud de Villeneuve | Montpellier | |
| France | Centre Hospitalier Intercommunal | Montreuil | |
| France | CHU Nantes Hotel Dieu | Nantes | |
| France | CHU Hôpital de l'Archet II | Nice | |
| France | Groupe Hospitalier Cochin Tarnier Port-Royal | Paris | |
| France | Groupe Hospitalier Necker | Paris | |
| France | Hôpital Robert Debré | Paris | |
| France | Hôpital Trousseau | Paris | |
| France | Centre Hospitalier Général- Hôpital Delafontaine | Saint-denis | |
| France | Hôpital Civil | Strasbourg | |
| France | CHU Paule de Viguier | Toulouse | |
| France | Centre Hospitalier Général | Villeneuve Saint Georges |
| Lead Sponsor | Collaborator |
|---|---|
| ANRS, Emerging Infectious Diseases |
France,
Aupiais C, Faye A, Le Chenadec J, Rouzioux C, Bouallag N, Laurent C, Blanche S, Dollfus C, Warszawski J; ANRS EPF-CO10 French Pediatric Cohort. Interruption of cART in clinical practice is associated with an increase in the long-term risk of subsequent im — View Citation
Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Rivière Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolesce — View Citation
Blanche S, Scott-Algara D, Le Chenadec J, Didier C, Montange T, Avettand-Fenoel V, Rouzioux C, Mélard A, Viard JP, Dollfus C, Bouallag N, Warszawski J, Buseyne F. Naive T lymphocytes and recent thymic emigrants are associated with HIV-1 disease history in — View Citation
Collaboration of Observational HIV Epidemiological Research Europe (COHERE) Study Group, Sabin CA, Smith CJ, d'Arminio Monforte A, Battegay M, Gabiano C, Galli L, Geelen S, Gibb D, Guiguet M, Judd A, Leport C, Dabis F, Pantazis N, Porter K, Raffi F, Thorn — View Citation
Dollfus C, Le Chenadec J, Faye A, Blanche S, Briand N, Rouzioux C, Warszawski J. Long-term outcomes in adolescents perinatally infected with HIV-1 and followed up since birth in the French perinatal cohort (EPF/ANRS CO10). Clin Infect Dis. 2010 Jul 15;51( — View Citation
Frange P, Faye A, Avettand-Fenoël V, Bellaton E, Descamps D, Angin M, David A, Caillat-Zucman S, Peytavin G, Dollfus C, Le Chenadec J, Warszawski J, Rouzioux C, Sáez-Cirión A; ANRS EPF-CO10 Pediatric Cohort and the ANRS EP47 VISCONTI study group. HIV-1 vi — View Citation
Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, Green H, Galli L, Ramos JT, Giaquinto C, Warszawski J, Levy J; European Infant Collaboration group. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected inf — View Citation
Goetghebuer T, Le Chenadec J, Haelterman E, Galli L, Dollfus C, Thorne C, Judd A, Keiser O, Ramos JT, Levy J, Warszawski J; European Infant Collaboration Group. Short- and long-term immunological and virological outcome in HIV-infected infants according t — View Citation
Judd A; European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Early antiretroviral therapy in HIV-1-infected infants, 1996-2008: treatment response and duration of first-line regimens. AIDS. 2011 Nov 28;25(18):2279- — View Citation
Pursuing Later Treatment Options II (PLATO II) project team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE), Castro H, Judd A, Gibb DM, Butler K, Lodwick RK, van Sighem A, Ramos JT, Warsawski J, Thorne C, Noguera-Julian — View Citation
Sofeu CL, Warszawski J, Ateba Ndongo F, Penda IC, Tetang Ndiang S, Guemkam G, Makwet N, Owona F, Kfutwah A, Tchendjou P, Texier G, Tchuente M, Faye A, Tejiokem MC; ANRS-PEDIACAM Study Group. Low birth weight in perinatally HIV-exposed uninfected infants: — View Citation
Warszawski J, Lechenadec J, Faye A, Dollfus C, Firtion G, Meyer L, Douard D, Monpoux F, Tricoire J, Benmebarek Y, Rouzioux C, Blanche S. Long-term nonprogression of HIV infection in children: evaluation of the ANRS prospective French Pediatric Cohort. Cli — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Conditions of access to early treatment | social factors (Geographical origin, living conditions, school level, age) and infection stage | At inclusion and every six months up to 18 years | |
| Secondary | Puberty stage | Tanner classification | At 8 years and every six months up to 18 years | |
| Secondary | Clinical prognosis | Health status (lipodystrophy, metabolic abnormalities, cardiovascular diseases, encephalopathy, Developmental delay, CDC stage) | At inclusion and every six months up to 18 years | |
| Secondary | Immuno virological prognosis | HIV RNA<50c/mL, CD4 cells count > 500 cells/mL, Genotypic resistance | At inclusion and every six months up to 18 years | |
| Secondary | Prognosis of patient coinfected by CMV or VHC | Adverse events of treatments (complications) | At inclusion and every six months up to 18 years | |
| Secondary | Sexuality | sexual risk behaviour (age at first intercourse, condom use at first, contraception, pregnancy, interruption of pregnancy) | At 15 years and every six months up to 18 years |