Brazilian Ministry of Health Oswaldo Cruz Foundation. Mariza G. Morgado, PhD Lab. AIDS & Molecular Immunology Oswaldo Cruz Institute

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1 Brazilian Ministry of Health Oswaldo Cruz Foundation Mariza G. Morgado, PhD. AIDS & Molecular Immunology Oswaldo Cruz Institute Fev 2006

2 HPTN Brazilian Sites NICHD/HPTN 040 PHASE III RAMDOMIZED TRIAL OF THE SAFETY AND EFFICACY OF THREE NEONATAL ANTIRETROVIRAL REGIMENS FOR PREVENTION OF INTRAPARTUM HIV-1 TRANSMISSION Start: April 2004 HPTN 052 A RANDOMIZED TRIAL TO EVALUATE THE EFFECTIVENESS OF HIV PRIMARY CARE VERSUS HIV PRIMARY CARE PLUS ANTIRETROVIRAL THERAPY TO PREVENT THE SEXUAL TRANSMISSION OF HIV-1 IN SERODISCORDANT COUPLES Start: September 2005 Belo Horizonte, MG Rio de Janeiro, RJ São Paulo,SP Porto Alegre, RS

3 Rio de Janeiro HPTN 052 Sites Central Beatriz Grinsztejn (PI) Clinical Mariza Morgado, PhD,. Director Maria da Gloria Bonecini, PhD J-C Couto Fernandez, PhD Graziela Moura, PhD Deise L. C. R Santos, M.Sc Rozeli Zancope, PhD Caio A Rodrigues, M.Sc Cristina Lourenco, M.Sc Roberta Lorete, M. Sc Jorge Nunes, B.Sc Carlos Jesus, B.Sc Italia Mazzei, B.Sc Rafael Santos, B.Sc HG NOVA IGUAÇU J. H. Pilotto (PI) Sabrina Castor, B.Sc Monica Torres, B.Sc Jaqueline Soares, B.Sc Jociane Melegario, B.Sc H SERVIDORES E Joao Filho (PI) Loredana Ceci, Pharm/Bioch Leila Cristina RF Silva

4 Oswaldo Cruz Foundation, RJ IOC-. AIDS & Molecular Immunology and IPEC-Clinical. International Research Projects: NICHD/HPTN 040; HPTN 052; AACTG5175; ANRS. coordination DNA processing/flow cabinet Flow cytometry Hematology and Biochemistry -70 o C freezers & biosafety areas PCR Genotyping

5 Hospital Geral de Nova Iguaçu, NI, RJ International Research Projects: NICHD/HPTN 040/ HPTN 052; ANRS oratory certifications: UKNEQAS (CD4), BR AIDS Program (CD4, VL) Blood Processing/Flow cabinet LDMS N2 container CD4-70 o C freezer

6 Hospital dos Servidores, Rio de Janeiro, RJ International Research Projects: NICHD/HPTN 040/ HPTN 052 oratory certifications: CAP (Viral markers, Microbiology), UKNEQAS (CD4), BR AIDS Program (CD4, VL), UMDNJ (cryopreservation), VQA (DNA AND RNA) N2 container Molecular biology facilities &Team

7 HPTN052 - Shipping, storage and testing of biological samples Hosp. Geral de Nova Iguacu Sample processing Sample storage LDMS CD4 counts Results Hospital dos Servidores Sample processing Sample storage LDMS Clinical specimens Transport of materials according to biosafety conditions; Direct contact with the study coordinator and clinical staff to minimize the delay between sample collection and laboratory results, RJ ldo Cruz Sample Foundation) processing Sample storage/ldms RNA assay CD4 counts Genotyping* Hematol./Biochem/Immunol/Microbiol Shipping & Training Clinical specimens Johns Hopkins Central

8 Oswaldo Cruz Foundation IPEC and IOC Certifications CAP : Hematology, Biochemistry, Microbiology, Serology for viral markers (HIV, Hepatitis B and C) and Syphilis, Parasitology. UKNEQAS: CD4 counts VQA: DNA PCR, RNA RT-PCR, GENOTYPING PBMC CRYOPRESERVATION

9 Hospital dos Servidores do Estado Contact Person: Loredana Ceci Telephone: / Hospital Geral de Nova Iguaçu Contact Person: Sabrina Santos da Silva Telephone: / Hospital Nossa Senhora da Conceicao/GHC Contact Person: Andrea Cauduro Castro Telephone: Instituto de Pesquisa Clínica Evandro Chagas Contact Person: Dr. Jorge Luiz Nunes da Silva Telephone: / oratory of AIDS and Molecular Immunology Contact Person: Deise LC Santos & Mariza Morgado (Head) Contact Hours: Monday-Friday, 8:00 am to 5:00 pm Telephone: Immunodiagnostic Contact Person: Ingebourg Georg & Maria da Gloria Bonecini (Head) Contact Hours: Monday-Friday, 8:00 am to 5:00 pm Telephone: (21) Instituto de Pesquisa Clínica Evandro Chagas Diagnósticos da oratory in Rio de Janeiro Contact Person: Dr. Adjelma de Almeida Melo. Telephone: / Sundays: Contact Person: Marcos Medeiros Tel: or Diagnósticos da oratory in São Paulo Contact Person: Telephone: / HPTN Central Contact Person: Estelle Piwowar-Manning Telephone: Fax: Hematolog y Chemistry CD4 oratory of AIDS and Molecular Immunol IOC/ HIV PCR RNA oratory of AIDS and Molecular Immuno IOC/ Genotyping oratory of AIDS and Molecular Immuno IOC/ HIV EIA Anti-body & HIV Western Blot oratory of Immunol Syphilis & Hepatitis B oratory of Immun Urine Pregnancy & Urinalysis Parasitology and Bacteriology Wet Mount Chlamydia Gonococcu s Diagnósticos da São Paulo HIV PCR Cervical / Seminal HPTN Central Herpes PCR Multiplex HPTN Central Diagnóstico s da Diagnóstic os da Hospital Geral de Nova Iguaçu Diagnóstico s da HPTN Central Hospital Nossa SenhoraDa Conceicao Diagnóstico s da Diagnóstico s da Diagnóstico s da N/A Hospital Nossa SenhoraDa Conceicao N/A N/A

10 Problems/corrective actions & positive suggestions during the 052 protocol start-up Requirement of specific reagents not easily available in the country Purchase of reagents/kits in large quantities/or well ahead of time Inadequate blood volume collection Standardization of visit specific forms, including relevant information for: blood collection (type of tubes/volumes) specimen processing (plasma, PBMC, whole blood); storage (no of aliquots, temp, etc) shipping (in country & Central )

11

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