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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Delavirdine mesylate  Drug: Didanosine	Phase III

Ages Eligible for Study:  14 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  352942041,  United States
California
      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
Colorado
      Univ Hosp / Univ of Colorado Health Sci Ctr, Denver,  Colorado,  80262,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      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
Georgia
      Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta,  Georgia,  30345,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
      Univ of Illinois, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Infectious Disease Research Clinic, Indianapolis,  Indiana,  46202,  United States
Iowa
      Univ of Iowa, Iowa City,  Iowa,  52242,  United States
Kansas
      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
Kentucky
      Univ of Kentucky Med Ctr / Chandler Med Ctr, Lexington,  Kentucky,  405360084,  United States
Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  701122699,  United States
Maine
      AIDS Consultation Service / Maine Med Ctr, Portland,  Maine,  04102,  United States
Maryland
      Univ of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States
Massachusetts
      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
Michigan
      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
Minnesota
      St Paul Ramsey Med Ctr / HIV Program Office, St. Paul,  Minnesota,  55101,  United States
Missouri
      Washington Univ, St. Louis,  Missouri,  63110,  United States
      Univ of Missouri at Kansas City School of Medicine, Kansas City,  Missouri,  64108,  United States
Nebraska
      Univ of Nebraska Med Ctr / HIV Clinic, Omaha,  Nebraska,  681985130,  United States
New Jersey
      Jersey Shore Med Ctr, Neptune,  New Jersey,  07753,  United States
New York
      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
North Carolina
      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
Ohio
      Univ of Cincinnati / Holmes Hosp, Cincinnati,  Ohio,  45267,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Pennsylvania
      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
Rhode Island
      Mem Hosp of Rhode Island, Pawtucket,  Rhode Island,  02860,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  29425,  United States
Tennessee
      Vanderbilt Univ, Nashville,  Tennessee,  37212,  United States
      Univ of Tennessee, Memphis,  Tennessee,  38163,  United States
Texas
      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
Vermont
      Med Ctr of Vermont Hosp, Burlington,  Vermont,  05401,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23219,  United States
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States
Wisconsin
      Univ of Wisconsin, Madison,  Wisconsin,  53792,  United States
Puerto Rico
      UPR School of Medicine, San Juan,  00936,  Puerto Rico

Study ID Numbers:  228A; M/3331/0017
Record last reviewed:  November 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002123
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08