The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine
NCT00002312 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL
Last updated 2005-06-24
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
Delavirdine mesylate
- DRUG
-
Zidovudine
Sponsors & Collaborators
-
Pharmacia and Upjohn
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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