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
ConditionsHIV Infections
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)HIV InfectionsNCT00000810National Institute of Allergy and Infectious Diseases (NIAID)120
Completed
Phase 3
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3HIV InfectionsNCT00002123Pharmacia and Upjohn
Completed
Phase 2
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and BabiesHIV InfectionsNCT00002210Pharmacia and Upjohn24
Completed
Not Applicable
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected PatientsHIV InfectionsNCT00002401Pharmacia and Upjohn160
Completed
Phase 2
A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination TherapyHIV InfectionsNCT00000803National Institute of Allergy and Infectious Diseases (NIAID)471