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Sponsored by: |
Pharmacia and Upjohn |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002124 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Delavirdine mesylate Drug: Lamivudine Drug: Zidovudine |
Phase III |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Lamivudine Delavirdine mesylate Delavirdine |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 1250 |
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.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
NOTE:
PER AMENDMENT 3/7/96:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Active substance abuse.
Show 88 Study Locations |
Pharmacia and Upjohn |
Study ID Numbers: | 228B, M/3331/0021 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002124 |
Health Authority: | United States: Food and Drug Administration |
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