A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3
- Conditions
- HIV Infections
- Registration Number
- NCT00002124
- Lead Sponsor
- Pharmacia and Upjohn
- Brief Summary
PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients.
PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.
- Detailed Description
PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo.
AS PER AMENDMENT 3/7/96:
PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III).
AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (88)
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Los Angeles County / Health Research Assoc / Drew Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Maryland at Baltimore
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Oncology and Hematology Association
🇺🇸Philadelphia, Pennsylvania, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Boston City Hosp / FGH-1
🇺🇸Boston, Massachusetts, United States
New England Deaconess Hosp
🇺🇸Boston, Massachusetts, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
St Lukes Medical Group
🇺🇸San Diego, California, United States
Univ of Cincinnati / Holmes Hosp
🇺🇸Cincinnati, Ohio, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Audie L Murphy Veterans Administration Hosp
🇺🇸San Antonio, Texas, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
AIDS Consultation Service / Maine Med Ctr
🇺🇸Portland, Maine, United States
Peachwood Med Ctr
🇺🇸Clovis, California, United States
Washington Univ
🇺🇸St. Louis, Missouri, United States
St Paul Ramsey Med Ctr / HIV Program Office
🇺🇸St. Paul, Minnesota, United States
Albany Med College
🇺🇸Albany, New York, United States
UCI Med Ctr
🇺🇸Orange, California, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Indiana Univ Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
UCD Med Ctr / AIDS and Related Disorders Clinic
🇺🇸Sacramento, California, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Univ of Missouri at Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
Shared Med Research Foundation
🇺🇸Tarzana, California, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
🇺🇸Atlanta, Georgia, United States
Saint Francis Mem Hosp
🇺🇸San Francisco, California, United States
UCSD / Ctr for Special Immunology
🇺🇸San Diego, California, United States
Univ Hosp / Univ of Colorado Health Sci Ctr
🇺🇸Denver, Colorado, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Univ of Iowa
🇺🇸Iowa City, Iowa, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Univ of Michigan Hospitals and Health Ctrs
🇺🇸Ann Arbor, Michigan, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Dallas Veterans Administration Med Ctr
🇺🇸Dallas, Texas, United States
Jersey Shore Med Ctr
🇺🇸Neptune, New Jersey, United States
Univ of Nebraska Med Ctr / HIV Clinic
🇺🇸Omaha, Nebraska, United States
Vanderbilt Univ
🇺🇸Nashville, Tennessee, United States
Community Research Initiative on AIDS
🇺🇸New York, New York, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Community Health Network
🇺🇸Rochester, New York, United States
Univ of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
New York Hosp - Cornell Med Ctr
🇺🇸New York, New York, United States
Univ of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Stratogen Health / Independent Research Nurses
🇺🇸Cranston, Rhode Island, United States
Pennsylvania State Univ / Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Med Ctr of Vermont Hosp
🇺🇸Burlington, Vermont, United States
Univ of Pennsylvania / HIV Clinic
🇺🇸Philadelphia, Pennsylvania, United States
Park Plaza Hosp
🇺🇸Houston, Texas, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
UPR School of Medicine
🇵🇷San Juan, Puerto Rico
Univ of Tennessee
🇺🇸Memphis, Tennessee, United States
Central Texas Med Foundation
🇺🇸Austin, Texas, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Univ of Wisconsin
🇺🇸Madison, Wisconsin, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
🇺🇸Stony Brook, New York, United States
New York Med College / Westchester County Med Ctr
🇺🇸Valhalla, New York, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
Davies Med Ctr
🇺🇸San Francisco, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
Caremark Inc
🇺🇸Palm Beach Gardens, Florida, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Univ of Kansas School of Medicine / Univ Hosp
🇺🇸Kansas City, Kansas, United States
Houston Veterans Administration Med Ctr
🇺🇸Houston, Texas, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
🇺🇸Lexington, Kentucky, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Harper Hosp
🇺🇸Detroit, Michigan, United States