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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

Phase 3
Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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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Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

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