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 & Upjohn

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Didanosine; Drug: Delavirdine mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002123

M/3331/0017

228A

Details and patient eligibility

About

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.

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.