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)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Peachwood Med Ctr
🇺🇸Clovis, 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
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
UCI Med Ctr
🇺🇸Orange, California, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
UCD Med Ctr / AIDS and Related Disorders Clinic
🇺🇸Sacramento, California, United States
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