Clinical Trial: A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3

This study has been completed.

Sponsored by: Pharmacia and Upjohn
Information provided by: AIDS Clinical Trials Information Service

Purpose

PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients. PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.

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

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

Further Study Details: 

Expected Total Enrollment:  1250

PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo. AS PER AMENDMENT 3/7/96: PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III). AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.

Eligibility

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

Criteria

Inclusion Criteria

Patients must have:

  • HIV-1 seropositivity.
  • CD4 count 200-500 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. PER AMENDMENT 3/7/96:
  • ZDV therapy for 0-6 months prior to study entry. (Part II) Prior Medication: Allowed:
  • Prior AZT (no more than 6 months total).

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 AZT in previously treated patients. Prior Medication: Excluded:
  • More than 6 months total of prior AZT.
  • Any prior ddC, d4T, 3TC, or ddI.
  • Prior non-nucleoside 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.
  • Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose. Active substance abuse.

Location Information


Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  352942041,  United States

California
      Peachwood Med Ctr, Clovis,  California,  93612,  United States

      ViRx Inc, San Francisco,  California,  94103,  United States

      AIDS Community Research Consortium, Redwood City,  California,  94063,  United States

      Highland Gen Hosp / San Francisco Gen Hosp, Oakland,  California,  946021018,  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

      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
      Johns Hopkins Hosp, Baltimore,  Maryland,  212052196,  United States

      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 Hosp of Cleveland / Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States

      Univ of Cincinnati / Holmes Hosp, Cincinnati,  Ohio,  45267,  United States

Oklahoma
      Univ of Oklahoma, Oklahoma City,  Oklahoma,  73117,  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

      Oncology and Hematology Association, Philadelphia,  Pennsylvania,  19146,  United States

      Univ of Pittsburgh Med School, Pittsburgh,  Pennsylvania,  15261,  United States

Rhode Island
      Stratogen Health / Independent Research Nurses, Cranston,  Rhode Island,  02910,  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
      Audie L Murphy Veterans Administration Hosp, San Antonio,  Texas,  78284,  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

      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

      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  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

More Information

Study ID Numbers:  228B; M/3331/0021
Record last reviewed:  July 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002124
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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