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Clinical Trials/NCT00002312
NCT00002312
Completed
Not Applicable

Open-Label Escalating Multiple-Dose Study of the Safety, Tolerance, and Pharmacokinetics of Oral U-90152 in HIV-1 Infected Males and Females With CD4 Counts of 200 - 500 Cells/mm3 Who Are Maintained on a Stable Dose of Zidovudine (AZT)

Pharmacia and Upjohn1 site in 1 countryAugust 31, 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Pharmacia and Upjohn
Locations
1
Status
Completed
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Pharmacia and Upjohn

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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