Pharmaceutical, MSG and NIH-Neurology Committee-sponsored Initiatives

Study Number and Sponsor	Study Title		Total Number of Subjects Enrolled		Number Subjects Active During 1998-99		Current Status
VX-94-6 Verex	A Multi-center Open Label Study to Evaluate the Safety & Efficacy of 300 mg Aztec, Given Twice Daily to Patients Who Are HIV + & Who Have Completed Clinical Protocol VX-93-3.		22		0		Closed
M/3331/0021 UpJohn/Pharmacia	A Double Blind, Randomized, Dose Response Study of Three Fixed Doses of Delavirdine Mesylate in Combination with ZDV vs. ZDV Alone in HIV Infected Individuals with CD4 Counts of 200-500 cells/mm3.		4		0		Closed
M/3331/0023 UpJohn/Pharmacia	Optional, Open Label, Extended Use Delavirdine Mesylate Treatment in Triple Combination for HIV-1+ Patients Who Participated in Other Delavirdine Mesylate Protocols.		3		1		Closed
SV14604 Hoffmann La Roche	A Randomized Multi-center Double Blind Phase III Parallel Study of ZDV alone vs. ZDV + ddC vs. ZDV + Saquinavir vs. ZDV + ddC + Saquinavir in Previously Untreated or Minimally Pretreated HIV Infected Patients with CD4 Counts from > 50 to < 350 Cells/mm3.		26		0		Closed
SV14788 Hoffmann La Roche	A Continuation Protocol with Open Label Saquinavir for HIV Infected Patients Who Have Completed A Clinical Trial With Saquinavir Treatment.		5		2		Closed
033 Merck	A Multi clinic, Double Blind, Randomized, 18 Month Study in HIV-1 Seropositive Patients to Compare the Efficacy & Safety of MK-639, 800 mg q8h, and Zidovudine (ZDV), 200 mg q8h Administered Concomitantly to MK-639 Alone and ZDV Alone.		16		0		Closed
M94-247 Abbott	A Phase III Safety & Efficacy Trial of ABT-538 + Current Therapy vs. Placebo + Current Therapy in HIV Infected Patients.		15		0		Closed
NV15107 Hoffmann La Roche	A Randomized, Parallel, Open Label Study Comparing Saquinavir (SQV) hard gelatin formulation 600 mg t.i.d. to SQV soft gelatin formulation (400, 800, 1200 mg t.i.d.) x 4 weeks in HIV Infected Patients.		8		1		Closed
M96-432 Abbott	A Phase III Ritonavir Long-Term Treatment Trial		5		0		Closed
GS-96-408 Gilead	A Multi-center Randomized, Double-blind, Placebo-Controlled Study of The Efficacy and Safety of Adefovir Dipivoxil when added to standard antiretroviral therapy for the treatment of HIV-Infected Patients with CD4 Cell Counts between 200 and 500/mm3		8		5		Ongoing/Closed to Accrual
DMP 66-20 DuPont Merck	A Phase III, Double-Blind, Placebo-Controlled, Multi-center Study to Determine the Effectiveness and tolerability of the Combination of DMP-266 and Indinavir vs Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy		4		4		Ongoing/Open To Accrual
NV15355 Hoffman La Roche	A randomized, Parallel Arm, Comparative, Open-Label, Multi-center Study of the Activity and Safety of Two Formulations of Saquinavir in Combination with Two Nucleoside Antiretroviral Drugs in Treatment Naive Patients		2		2		Ongoing/Closed To Accrual
Glaxo Wellcome CNAA/B3005	A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected, Antiretroviral Therapy Naive Subjects		8		7		New Study: Ongoing/Closed To Accrual
GlaxoWellcome PROA/B3006	A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 with Indinavir in Combination with Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy in NRTI Experienced, Protease Inhibitor (PI) Naive HIV-1 Infected Patients		0		0		Closed before opened locally
Triangle Pharmaceutical	A Randomized, Double-Blind Study of MKC-442 Combined with Viracept in Patients Who Are EpivirTM + Retrovir 7 Experienced and are Protease-Inhibitor and Non-Nucleoside Reverse Transcriptase-Inhibitor Naive		0		0		New Study: Ongoing/Closed To Accrual
MSG #34 Mycoses Study Group	Prospective, Multi-center, Hospital-Based Epidemiology Study of Candidemia		96		44		Ongoing/Open to Accrual
MSG # 36 Mycoses Study Group	A Multi-center, Case-Control Study of Risk Factors For Histoplasmosis in Patients with HIV		6		1		Ongoing/Open to Accrual
NARC 001	Natural History of Human Immunodeficiency Virus (HIV) Associated Progressive Multi focal Leukoencephalopathy (PML) in the Era of Protease Inhibitors		2		1		Ongoing/Open to Accrual
Pfizer 150-602	An Open Randomized Comparative Multi-center Study of The Efficacy, Safety and Toleration of Voriconazole vs Amphotericin B Followed By Other Licensed Antifungal Therapy In The Treatment of Acute Invasive Aspergillosis In Immunocompromised Patients		0		0		New Study: Ongoing/Closed To Accrual
Pfizer 150-603 (MSG # 42)	A Randomized, Open Label, Comparative, Multi-center Trial of Voriconazole vs. AmBisome 7 for Empirical Antifungal Therapy in Immunocompromised Patients with Persistent Fever and Neutropenia		0		0		New Study: Ongoing/Closed To Accrual
Pfizer 150-604	An Open Label, Non-comparative, Multi-center, Phase III Trial of the Efficacy, Safety and Toleration of voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections		0		0		New Study: Ongoing/Closed To Accrual
Pfizer RO437 (MSG # 33)	A Randomized, Double Blind Comparative Multi-center Study o Fluconazole plus Amphotericin B vs Fluconazole plus placebo in the Treatment of Candidemia and its Consequences in Non-Neutropenic Patients		0		0		New Study: Ongoing/Closed To Accrual

This page last modified 3/1/99.