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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Delavirdine mesylate
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Concurrent Medication: Allowed: AZT. Patients must have: HIV-1 seropositivity. CD4 count <= 300 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. 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: Excluded: 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. Required: AZT therapy at some time prior to screening. Active substance abuse.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Delavirdine mesylate|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents