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.

Study Timeline

• Status Verified: 1997-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

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

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

Scroll for more (78 remaining)