The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002312
• Lead Sponsor: Pharmacia and Upjohn

Brief Summary

To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 ) after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained on a stable dose of zidovudine ( AZT ). To investigate the optimum dose regimen of U-90152 that gives average trough concentrations \> 1 micromolar in combination with standard AZT therapy, and to examine drug interactions between the two drugs. To establish the MTD of U-90152 in HIV-1 positive patients on stable AZT therapy. To investigate comparative pharmacokinetics between HIV-1 positive men and women.

Detailed Description

Not available

Study Timeline

• Status Verified: 1994-04
• 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: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Bronson Methodist Hosp / Upjohn Research Clinic; 🇺🇸 Kalamazoo, Michigan, United States