PERFORMANCE SITE ESTABLISHMENT PLAN
SECTION I – SITE SPECIFIC INFORMATION
Performance Site Name (institution) and location: (include a complete physical
Performance Site Number:
address)
12201 (PTN 10-004)
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS Brazil
Phone: 011-55-51-3341-5316
Fax: 011-55-51-3343-2386
Name of the Awardee Institution
Main Unit
Location of central coordination for this performance
(Main Unit):
Number:
site: (e.g. where data are processed and/or regulatory and other
University of California, Los Angeles
60466
Principal Investigator (PI) on the Notice of Grant
Award: (name, address, phone, fax and email of main unit PI)
Yvonne Bryson, M.D.
UCLA Children’s Hospital
10833 Le Conte Avenue
MDCC 22-442
Los Angeles, CA 90095-1752
Phone: (310) 825-5235
Fax: (310) 206-5529
[email protected]
On site PI, for non-US sites: (name, address, phone, fax
and email of local counterpart to main unit PI, if applicable)
study related files are maintained; may be same as above; include
complete address)
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316
Fax: 011-55-51-3343-2386
(for data management only)
Site Coordinator: (Individual on site who is responsible for the
day to day administrative and other oversight and coordination,
regardless of formal job title) (name, address, phone, fax and
email)
Rita de Cássia Alves Lira, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected] and [email protected]
Health and Human Services Assurance Numbers
assigned: (Include current MPA, CPA, and/or FWA, if available.
Include name of institution to which number is assigned and
Breno Riegel Santos, M.D.
expiration date).
Hospital Nossa Senhora da Conceição
UCLA: FWA 00004642, Expiration Date: 16 March, 2009
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Hospital Nossa Senhora da Conceição:
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
FWA 00000378, Expiration Date: 8 March 2010
[email protected]
Institutional Review Board(s) responsible for research at this site: (Include full name and address of all IRBs
responsible for overseeing the research at this site. For international sites, include both in-country and US IRB, if applicable)
Comitê de Ética em Pesquisa do Grupo Hospitalar
Conceição-GHC
(Institutional Review Board)
Av. Francisco Trein, 596
91350-200 Porto Alegre, RS Brazil
IRB Chairperson: Lauro Luis Hagemann, Physician
UCLA Office for Protection of Research Subjects
Medical Institutional Review Board
2107 Ueberroth Bldg.
Los Angeles, CA 90024
IRB Chairperson: Robert A. Figlin, M.D.
Chair, Medical Institutional
Review Board #2
CONEP: Comissão Nacional de Ética em Pesquisa.
Ministério da Saúde, Anexo, Ala – B, 1° Andar.
Esplanada dos Ministérios.
Brasília – DF
CEP: 70058-900.
Brazil.
Revised by J. Talley 30 April 2008.
Page 1 of 3
Section II Study Specific Information (This section should be copied and completed for each HPTN study at this
Performance Site)
Study Number and Title:
IND #, if applicable: Will prisoners be
HPTN 052: A Randomized Trial to Evaluate the Effectiveness of
enrolled or followed?
Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to 68,535
Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples
No
Affiliated Sites:
On site Study Coordinator:
(sub-sites at which the study will be conducted that are
physically in a separate location from the performance site but
are under the same IRB, same Investigator of Record)
None
(name, address, phone, fax and email)
Rita de Cássia Alves Lira, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected] and [email protected]
On site Study Data Manager:
(name, address, phone, fax and email)
Investigator of Record (individual who signs the Form
1572 (for IND studies) or HPTN Investigator Agreement (for
non-IND studies) (name, address, phone, fax and email)
Breno Riegel Santos, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre,
RS Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected]
Local Laboratory Facilities for this study: (Include
name and address of all local lab facilities to be used in the
study, whether on-site or off site. Do not include the HPTN
Central Lab.)
Rui Flores, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected]
Other Lead or Key Study Investigator(s) who should be
included in all correspondence regarding this study (whether on
site or in US; may include more than one, if applicable) (name,
address, phone, fax and email)
1. Kelin Roberta Zabtoski, Psychologist – Study Coordinator
Jr: [email protected]
2. Marineide Melo Rocha, M.D. [email protected]
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
Name of Pharmacist and location of on site Pharmacy
facility for this study (where products will be received and
centrally stored).
Laboratorio Central
Hospital Nossa Senhora da Conceição
Av. Francisco Trein, 596 CEP: 91350-200
Porto Alegre, RS Brazil
Phone/Fax:011-55-51-3362-2185
FHI Research Manager for this study: (name and email)
Elizabeth Magalhaes, Pharmacist
Hospital Nossa Senhora da Conceição
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone/Fax:011-55-51-3362-2183
[email protected]
SCHARP Protocol Operations Coordinator for this
study: (name and email)
Theresa Gamble, [email protected]
Marybeth McCauley, [email protected]
Jackie Talley, [email protected]
Leslie Cottle, [email protected]
Revised by J. Talley 30 April 2008.
Page 2 of 3
Section II Study Specific Information (This section should be copied and completed for each HPTN study at this
Performance Site)
Study Number and Title:
IND #, if applicable: Will prisoners be
HPTN 057: A Phase I Open Label Trial of the Safety and
enrolled or followed?
72,531
Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected
No
Pregnant Women and their Infants
Affiliated Sites:
On site Study Coordinator:
(sub-sites at which the study will be conducted that are
physically in a separate location from the performance site but
are under the same IRB, same Investigator of Record)
(name, address, phone, fax and email)
None
Rita de Cássia Alves Lira, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected] and [email protected]
On site Study Data Manager:
(name, address, phone, fax and email)
Investigator of Record (individual who signs the Form
1572 (for IND studies) or HPTN Investigator Agreement (for
non-IND studies) (name, address, phone, fax and email)
Breno Riegel Santos, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre,
RS Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected]
Rui Flores, M.D.
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
[email protected]
Other Lead or Key Study Investigator(s) who should be
included in all correspondence regarding this study (whether on
site or in US; may include more than one, if applicable) (name,
address, phone, fax and email)
Hospital Nossa Senhora da Conceição
Servico de Infectologia
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone: 011-55-51-3341-5316, Fax:011-55-51-3343-2386
Nielsen, Karin M.D. E-mail: [email protected]
Local Laboratory Facilities for this study: (Include
Name of Pharmacist and location of on site Pharmacy
facility for this study (where products will be received and
name and address of all local lab facilities to be used in the
study, whether on-site or off site. Do not include the HPTN
Central Lab.)
centrally stored).
Laboratorio Central
Hospital Nossa Senhora da Conceição
Av. Francisco Trein, 596 CEP: 91350-200
Porto Alegre, RS Brazil
Phone/Fax:011-55-51-3362-2185
Elizabeth Magalhaes, Pharmacist
Hospital Nossa Senhora da Conceição
Av. Francisco Trein, 596 CEP: 91350-200 Porto Alegre, RS
Brazil
Phone/Fax:011-55-51-3362-2183
[email protected]
FHI Research Manager for this study: (name and email)
SCHARP Protocol Operations Coordinator for this
study: (name and email)
Kathy George : [email protected]
Lynda Emel: [email protected]
Revised by J. Talley 30 April 2008.
Page 3 of 3