NCT00002123CompletedPhase 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/mm3
Pharmacia and Upjohn168 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Locations
- 168
Study Overview
Brief Summary
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •Patients must have:
- •HIV-1 seropositivity.
- •CD4 count <= 300 cells/mm
- •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.
- •Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.
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 ddI in previous treated patients.
- •Prior Medication:
- •More than 4 months total of prior ddI.
- •Any prior ddC, d4T, or 3TC.
- •Prior nonnucleoside 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.
- •AZT therapy at some time prior to screening. Active substance abuse.
Investigators
Study Sites (168)
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