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
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
Eligibility 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.
Sites / Locations
- Univ of Alabama at Birmingham
- East Bay AIDS Ctr
- California Med Research Group
- Los Angeles County - USC Med Ctr
- Los Angeles County / Health Research Assoc / Drew Med Ctr
- CARE Ctr / UCLA Med Ctr
- UCI Med Ctr
- AIDS Community Research Consortium
- UCD Med Ctr / AIDS and Related Disorders Clinic
- St Lukes Medical Group
- UCSD / Ctr for Special Immunology
- ViRx Inc
- Saint Francis Mem Hosp
- Davies Med Ctr
- Shared Med Research Foundation
- Harbor - UCLA Med Ctr
- Univ Hosp / Univ of Colorado Health Sci Ctr
- Georgetown Univ Med Ctr
- George Washington Univ Med Ctr
- Univ of Miami School of Medicine
- Caremark Inc
- Infectious Disease Research Institute Inc
- Infectious Disease Rsch Consortium of GA / SE Clin Resources
- Rush Presbyterian - Saint Luke's Med Ctr
- Univ of Illinois
- Indiana Univ Infectious Disease Research Clinic
- Univ of Iowa
- Univ of Kansas School of Medicine / Univ Hosp
- Univ of Kansas School of Medicine
- Univ of Kentucky Med Ctr / Chandler Med Ctr
- Tulane Univ Med School
- AIDS Consultation Service / Maine Med Ctr
- Univ of Maryland at Baltimore
- Massachusetts Gen Hosp
- Brigham and Women's Hosp
- Boston City Hosp / FGH-1
- New England Deaconess Hosp
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med Ctr
- Univ of Michigan Hospitals and Health Ctrs
- Harper Hosp
- Henry Ford Hosp
- St Paul Ramsey Med Ctr / HIV Program Office
- Univ of Missouri at Kansas City School of Medicine
- Washington Univ
- Univ of Nebraska Med Ctr / HIV Clinic
- Jersey Shore Med Ctr
- Albany Med College
- SUNY / Erie County Med Ctr at Buffalo
- Community Research Initiative on AIDS
- Beth Israel Med Ctr
- Saint Vincent's Hosp and Med Ctr
- New York Hosp - Cornell Med Ctr
- Mount Sinai Med Ctr
- Community Health Network
- Univ of Rochester Med Ctr
- SUNY / Health Sciences Ctr at Stony Brook
- New York Med College / Westchester County Med Ctr
- Univ of North Carolina School of Medicine
- Carolinas Med Ctr
- Duke Univ Med Ctr
- Univ of Cincinnati / Holmes Hosp
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Pennsylvania State Univ / Hershey Med Ctr
- Children's Hosp of Philadelphia
- Univ of Pennsylvania / HIV Clinic
- Buckley Braffman Stern Med Associates
- Oncology and Hematology Association
- Univ of Pittsburgh Med School
- Mem Hosp of Rhode Island
- Med Univ of South Carolina
- Univ of Tennessee
- Vanderbilt Univ
- Central Texas Med Foundation
- Dallas Veterans Administration Med Ctr
- Park Plaza Hosp
- Houston Veterans Administration Med Ctr
- Univ TX Health Science Ctr
- Univ TX San Antonio Health Science Ctr
- Med Ctr of Vermont Hosp
- Richmond AIDS Consortium
- Univ of Washington
- Univ of Wisconsin
- UPR School of Medicine