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
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.
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.
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
East Bay AIDS Ctr
Berkeley, California, United States
California Med Research Group
Fresno, 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
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
...and 74 more locations
NCT00002123 - 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 | Crick | Crick