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HIV Clinical Trials Track Record


SUNY Downstate Medical Center
HIV/AIDS Research Project & HIV Clinical Trials Track Record

1991 - Present



Year(s) Study Open Name of Study

Sponsor

Local Principal/Co-
Investigators

Subject Accrual


Cohort Studies




1992-present Women & Infant Transmission Study (WITS) NICHD S. Landesman
E. Handelsman
296
1994-present Women's Interagency HIV Study (WIHS) NIAID/
NIDA/NCI
H. Minkoff /
J. DeHovitz
609
1996-1999 Determinants of HIV Testing & Perinatal ZDV Use CDC J. DeHovitz /
H. Minkoff
684
2001-2003 HIV Practice Cooperative- "Observation Study to Assess Patient Attitudes About Antiretroviral Medication Changes" Merck J. DeHovitz 60
2002-present HIV Treatment Adherence Demonstration Project NYS AIDS Institute T. Wilson 60
2002 - present Observational Study of Treated and Untreated Acute and Early HIV-1 Infection AIEDRP M. Markowitz
1
2002- present A Large Simple Trial Comparing Two Strategies for Management of Antiretroviral Therapy NIAIDS/DAIDS J. DeHovitz
20
Diagnostic Studies
1998-1999 Identification of HIV-1 urine antibody positive, HIV-1 seronegative individuals Calypte J. DeHovitz 149
Clinical Treatment Trials
1991-present Pediatric AIDS Clinical Trials Unit (KCHC) NICHD/NIAID H. Mendez/
E. Handelsman
50
1998-2000 Phase IV study of Procrit given weekly Ortho Biotech S. Burney
14
1999-2001 Phase IIb study of Indinavir/Ritonavir twice a day plus3TC/d4T Merck J. DeHovitz
4
1999-2001 Phase IV study of gender differences in the pharmacokinetics of nelfinavir Agouron D. Singh/
R. Sharma/
J. Quale/
30
2000-2001 Expanded Access Program for ABT-378r (Kaletra) Abbott J. DeHovitz
8
2001 Expanded Access Program for Tenofovir DF (Viread) Gilead Sciences 7
2001 - 2003 HIV Resistance Study I & II NYS Dept. of Health 200
2002 Phase 2, Double-blind, Randomized, Placebo-controlled Study of Capravirine in Combination with Viracept Agouron/
Pfizer

J. DeHovitz
2
2002 Phase IIIB Atazanavir for HIV Infected Individuals: An Early Access Program BMS 7
2002 VEST-QD: A Phace IV, Open-label, Randonmized, Multicenter Study Switching HIV-1 Infected Subjects to an Efavirenz Substitution Regimen BMS
J. DeHovitz
4