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

Launched by PHARMACIA AND UPJOHN · Aug 30, 2001

Keywords

ClinConnect Summary

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 ant...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV-1 seropositivity.
• • CD4 count 200-500 cells/mm3.
• • No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV).
• • Consent of parent or guardian if less than 18 years of age.
• • Understanding of potential risk to fetus related to study participation.
• • Acceptable medical history, physical exam, EKG, and chest x-ray during screening.
• NOTE:
• • Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.
• PER AMENDMENT 3/7/96:
• • ZDV therapy for 0-6 months prior to study entry. (Part II)
• Prior Medication:
• Allowed:
• • Prior AZT (no more than 6 months total).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Active tuberculosis that is sensitive to rifampin.
• • Inability to swallow numerous tablets.
• • Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy.
• • Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine).
• * Grade 2 or worse baseline organ function. NOTE:
• * Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE:
• • Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better.
• Patients with the following prior conditions are excluded:
• • History of pancreatitis within the past 2 years.
• • History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance.
• • History of grade 2 or worse peripheral neuropathy.
• • Intolerance to AZT in previously treated patients.
• Prior Medication:
• Excluded:
• • More than 6 months total of prior AZT.
• • Any prior ddC, d4T, 3TC, or ddI.
• • Prior non-nucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA.
• • Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose.
• • Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines.
• • Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose.
• • Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose.
• • Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose.
• • Active substance abuse.