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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002124

Run by

Pharmacia and Upjohn

People needed

1250

Last updated by the study team

2005-06-24

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Peachwood Med Ctr — Clovis, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Los Angeles County / Health Research Assoc / Drew Med Ctr — Los Angeles, California, United States
• CARE Ctr / UCLA Med Ctr — Los Angeles, California, United States
• Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
• UCI Med Ctr — Orange, California, United States
• AIDS Community Research Consortium — Redwood City, California, United States
• UCD Med Ctr / AIDS and Related Disorders Clinic — Sacramento, California, United States
• St Lukes Medical Group — San Diego, California, United States
• UCSD / Ctr for Special Immunology — San Diego, California, United States
• ViRx Inc — San Francisco, California, United States
• Saint Francis Mem Hosp — San Francisco, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Shared Med Research Foundation — Tarzana, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Univ Hosp / Univ of Colorado Health Sci Ctr — Denver, Colorado, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Caremark Inc — Palm Beach Gardens, Florida, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Infectious Disease Rsch Consortium of GA / SE Clin Resources — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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