HIV Adult Clinical Trials Program

CLINICAL RESEARCH SUMMARY:

COHORT STUDIES
Year(s) Study Active	Name of Study	Sponsor	PI/Co-Investigators	Subject Accrual	Target Subject Accrual
To open in 2008	HIV Elite Controllers Study	Partners AIDS Research Center (Mass. General Hospital)	J. Ravishankar		5 to 10
To open in 2008	The Manhattan HIV Brain Bank	Mt. Sinai Medical Center (NIH)	H. Crystal		50
2005-present	Substance Abuse and HIV: Genetics & Disease Progression	NIMH	H. Crystal	1600
1994-present	Women's Interagency HIV Study (WIHS)	NIAID/NCI/NIDA	H. Minkoff	611
1992-present	Women & Infant Transmission Study (WITS)	NICHD/ NIAID	H. Mendez	300
CLINICAL TRIALS
To open in 2008	A randomized, dose changing, active comparator study exploring the safety, tolerability, pharmacokinetics and virologic effect of once daily oral dosing of INCB009471 compared to twice daily oral dosing of maraviroc in addition to optimized background therapy, in therapy experienced HIV-1 infected subjects who harbor R5 tropic virus	Incyte	J. Ravishankar		2
2007-present	Early Access of MK-0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients with Limited to No Treatment Options	Merck	J. Ravishankar	8
2004-present	A Phase IV, Multi-center, Cross-sectional Study to Evaluate the I50L Substitution among Subjects Experiencing Virologic Failure on a HAART regimen containing Atazanavir (ATV)	Bristol Myers Squibb	J. Ravishankar	10
2004-present	A Multicenter, randomized, double-blind, comparative trial of a novel CCR5 antagonist, UK-427,857, in combination with zidovudine/lamivudine versus efavirenz in combination with zidovudine/lamivudine for the treatment of antiretroviral-naïve HIV-1 infected subjects	Pfizer	J. Ravishankar	1
2004-present	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of A Novel CCR5 Antagonist, UK-427,857, In Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects	Pfizer	J. Ravishankar	3
2004-present	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of A Novel CCR5 Antagonist, UK-427,857, In Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced, Non CCR5-Tropic HIV-1 Infected Subjects	Pfizer	J. Ravishankar	1
OTHER CLINICAL RESEARCH PROJECTS
To open in 2008	Retention in Care	Centers for Disease Control and Prevention	T. Wilson		200
To open in 2008	African American Heterosexual HIV Risk Reduction	Centers for Disease Control and Prevention	T. Wilson		200
Aug-07	Victimization & medication adherence among HIV+ women	SUNY Downstate Dean's Award	R. Schwartz		300