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
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002123
- Run by
- Pharmacia and Upjohn
- 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…
- 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.
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 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.
Where it is running
- 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
- 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 Illinois — Chicago, Illinois, United States
- Univ of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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