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.
UPR School of Medicine, San Juan 00936, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 352942041, United States
ViRx Inc, San Francisco, California 94103, United States
AIDS Community Research Consortium, Redwood City, California 94063, United States
UCD Med Ctr / AIDS and Related Disorders Clinic, Sacramento, California 95817, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 900331079, United States
Harbor - UCLA Med Ctr, Torrance, California 90509, United States
Shared Med Research Foundation, Tarzana, California 91356, United States
UCSD / Ctr for Special Immunology, San Diego, California 92103, United States
Los Angeles County / Health Research Assoc / Drew Med Ctr, Los Angeles, California 90059, United States
Saint Francis Mem Hosp, San Francisco, California 94109, United States
California Med Research Group, Fresno, California 93726, United States
St Lukes Medical Group, San Diego, California 92101, United States
CARE Ctr / UCLA Med Ctr, Los Angeles, California 90095, United States
UCI Med Ctr, Orange, California 92668, United States
Davies Med Ctr, San Francisco, California 94114, United States
Univ Hosp / Univ of Colorado Health Sci Ctr, Denver, Colorado 80262, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Univ of Miami School of Medicine, Miami, Florida 33136, United States
Caremark Inc, Palm Beach Gardens, Florida 33410, United States
Infectious Disease Research Institute Inc, Tampa, Florida 33614, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta, Georgia 30345, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Univ of Illinois, Chicago, Illinois 60612, United States
Indiana Univ Infectious Disease Research Clinic, Indianapolis, Indiana 46202, United States
Univ of Iowa, Iowa City, Iowa 52242, United States
Univ of Kansas School of Medicine / Univ Hosp, Kansas City, Kansas 661607354, United States
Univ of Kansas School of Medicine, Wichita, Kansas 67214, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr, Lexington, Kentucky 405360084, United States
Tulane Univ Med School, New Orleans, Louisiana 701122699, United States
AIDS Consultation Service / Maine Med Ctr, Portland, Maine 04102, United States
Univ of Maryland at Baltimore, Baltimore, Maryland 21201, United States
Massachusetts Gen Hosp, Boston, Massachusetts 02114, United States
Univ of Massachusetts Med Ctr, Worcester, Massachusetts 01655, United States
New England Deaconess Hosp, Boston, Massachusetts 02215, United States
Boston City Hosp / FGH-1, Boston, Massachusetts 02118, United States
Brigham and Women's Hosp, Boston, Massachusetts 02115, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States
Harper Hosp, Detroit, Michigan 48201, United States
Univ of Michigan Hospitals and Health Ctrs, Ann Arbor, Michigan 481090378, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
St Paul Ramsey Med Ctr / HIV Program Office, St. Paul, Minnesota 55101, United States
Washington Univ, St. Louis, Missouri 63110, United States
Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States
Univ of Nebraska Med Ctr / HIV Clinic, Omaha, Nebraska 681985130, United States
Jersey Shore Med Ctr, Neptune, New Jersey 07753, United States
New York Med College / Westchester County Med Ctr, Valhalla, New York 10595, United States
Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States
Univ of Rochester Med Ctr, Rochester, New York 14642, United States
Albany Med College, Albany, New York 122083479, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States
Community Research Initiative on AIDS, New York, New York 10001, United States
Community Health Network, Rochester, New York 14620, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States
Beth Israel Med Ctr, New York, New York 10003, United States
New York Hosp - Cornell Med Ctr, New York, New York 10021, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Carolinas Med Ctr, Charlotte, North Carolina 28204, United States
Univ of North Carolina School of Medicine, Chapel Hill, North Carolina 275997215, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Univ of Cincinnati / Holmes Hosp, Cincinnati, Ohio 45267, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States
Univ of Pennsylvania / HIV Clinic, Philadelphia, Pennsylvania 19104, United States
Pennsylvania State Univ / Hershey Med Ctr, Hershey, Pennsylvania 17033, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Oncology and Hematology Association, Philadelphia, Pennsylvania 19146, United States
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania 15261, United States
Mem Hosp of Rhode Island, Pawtucket, Rhode Island 02860, United States
Med Univ of South Carolina, Charleston, South Carolina 29425, United States
Vanderbilt Univ, Nashville, Tennessee 37212, United States
Univ of Tennessee, Memphis, Tennessee 38163, United States
Park Plaza Hosp, Houston, Texas 77004, United States
Houston Veterans Administration Med Ctr, Houston, Texas 77030, United States
Univ TX Health Science Ctr, Houston, Texas 77030, United States
Dallas Veterans Administration Med Ctr, Dallas, Texas 75216, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States
Central Texas Med Foundation, Austin, Texas 78751, United States
Med Ctr of Vermont Hosp, Burlington, Vermont 05401, United States
Richmond AIDS Consortium, Richmond, Virginia 23219, United States
Univ of Washington, Seattle, Washington 98104, United States
Univ of Wisconsin, Madison, Wisconsin 53792, United States
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Cox SR, Edge-Padbury BA, Carberry PA, Wathen LK. Delavirdine (DLV) + didanosine (ddI) combination therapy has sustained surrogate marker response in advanced HIV-1 population. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163
