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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

Sponsor
Pharmacia and Upjohn (Industry)
Overall Status
Completed
CT.gov ID
NCT00002124
Collaborator
(none)
1,250
Enrollment
88
Locations
14.2
Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univ of Alabama at Birmingham Birmingham Alabama United States 352942041
    2 East Bay AIDS Ctr Berkeley California United States 94705
    3 Peachwood Med Ctr Clovis California United States 93612
    4 Los Angeles County - USC Med Ctr Los Angeles California United States 900331079
    5 Los Angeles County / Health Research Assoc / Drew Med Ctr Los Angeles California United States 90059
    6 CARE Ctr / UCLA Med Ctr Los Angeles California United States 90095
    7 Highland Gen Hosp / San Francisco Gen Hosp Oakland California United States 946021018
    8 UCI Med Ctr Orange California United States 92668
    9 AIDS Community Research Consortium Redwood City California United States 94063
    10 UCD Med Ctr / AIDS and Related Disorders Clinic Sacramento California United States 95817
    11 St Lukes Medical Group San Diego California United States 92101
    12 UCSD / Ctr for Special Immunology San Diego California United States 92103
    13 ViRx Inc San Francisco California United States 94103
    14 Saint Francis Mem Hosp San Francisco California United States 94109
    15 Davies Med Ctr San Francisco California United States 94114
    16 Shared Med Research Foundation Tarzana California United States 91356
    17 Harbor - UCLA Med Ctr Torrance California United States 90509
    18 Univ Hosp / Univ of Colorado Health Sci Ctr Denver Colorado United States 80262
    19 Georgetown Univ Med Ctr Washington District of Columbia United States 20007
    20 George Washington Univ Med Ctr Washington District of Columbia United States 20037
    21 Univ of Miami School of Medicine Miami Florida United States 33136
    22 Caremark Inc Palm Beach Gardens Florida United States 33410
    23 Infectious Disease Research Institute Inc Tampa Florida United States 33614
    24 Infectious Disease Rsch Consortium of GA / SE Clin Resources Atlanta Georgia United States 30345
    25 Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois United States 60612
    26 Univ of Illinois Chicago Illinois United States 60612
    27 Indiana Univ Infectious Disease Research Clinic Indianapolis Indiana United States 46202
    28 Univ of Iowa Iowa City Iowa United States 52242
    29 Univ of Kansas School of Medicine / Univ Hosp Kansas City Kansas United States 661607354
    30 Univ of Kansas School of Medicine Wichita Kansas United States 67214
    31 Univ of Kentucky Med Ctr / Chandler Med Ctr Lexington Kentucky United States 405360084
    32 Tulane Univ Med School New Orleans Louisiana United States 701122699
    33 AIDS Consultation Service / Maine Med Ctr Portland Maine United States 04102
    34 Univ of Maryland at Baltimore Baltimore Maryland United States 21201
    35 Johns Hopkins Hosp Baltimore Maryland United States 212052196
    36 Massachusetts Gen Hosp Boston Massachusetts United States 02114
    37 Brigham and Women's Hosp Boston Massachusetts United States 02115
    38 Boston City Hosp / FGH-1 Boston Massachusetts United States 02118
    39 New England Deaconess Hosp Boston Massachusetts United States 02215
    40 Baystate Med Ctr of Springfield Springfield Massachusetts United States 01199
    41 Univ of Massachusetts Med Ctr Worcester Massachusetts United States 01655
    42 Univ of Michigan Hospitals and Health Ctrs Ann Arbor Michigan United States 481090378
    43 Harper Hosp Detroit Michigan United States 48201
    44 Henry Ford Hosp Detroit Michigan United States 48202
    45 St Paul Ramsey Med Ctr / HIV Program Office St. Paul Minnesota United States 55101
    46 Univ of Missouri at Kansas City School of Medicine Kansas City Missouri United States 64108
    47 Washington Univ St. Louis Missouri United States 63110
    48 Univ of Nebraska Med Ctr / HIV Clinic Omaha Nebraska United States 681985130
    49 Jersey Shore Med Ctr Neptune New Jersey United States 07753
    50 Albany Med College Albany New York United States 122083479
    51 SUNY / Erie County Med Ctr at Buffalo Buffalo New York United States 14215
    52 Community Research Initiative on AIDS New York New York United States 10001
    53 Beth Israel Med Ctr New York New York United States 10003
    54 Saint Vincent's Hosp and Med Ctr New York New York United States 10011
    55 New York Hosp - Cornell Med Ctr New York New York United States 10021
    56 Mount Sinai Med Ctr New York New York United States 10029
    57 Community Health Network Rochester New York United States 14620
    58 Univ of Rochester Med Ctr Rochester New York United States 14642
    59 SUNY / Health Sciences Ctr at Stony Brook Stony Brook New York United States 117948153
    60 New York Med College / Westchester County Med Ctr Valhalla New York United States 10595
    61 Univ of North Carolina School of Medicine Chapel Hill North Carolina United States 275997215
    62 Carolinas Med Ctr Charlotte North Carolina United States 28204
    63 Duke Univ Med Ctr Durham North Carolina United States 27710
    64 Univ of Cincinnati / Holmes Hosp Cincinnati Ohio United States 45267
    65 Univ Hosp of Cleveland / Case Western Reserve Univ Cleveland Ohio United States 44106
    66 Univ of Oklahoma Oklahoma City Oklahoma United States 73117
    67 Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon United States 97210
    68 Pennsylvania State Univ / Hershey Med Ctr Hershey Pennsylvania United States 17033
    69 Univ of Pennsylvania / HIV Clinic Philadelphia Pennsylvania United States 19104
    70 Buckley Braffman Stern Med Associates Philadelphia Pennsylvania United States 19107
    71 Oncology and Hematology Association Philadelphia Pennsylvania United States 19146
    72 Univ of Pittsburgh Med School Pittsburgh Pennsylvania United States 15261
    73 Stratogen Health / Independent Research Nurses Cranston Rhode Island United States 02910
    74 Med Univ of South Carolina Charleston South Carolina United States 29425
    75 Univ of Tennessee Memphis Tennessee United States 38163
    76 Vanderbilt Univ Nashville Tennessee United States 37212
    77 Central Texas Med Foundation Austin Texas United States 78751
    78 Dallas Veterans Administration Med Ctr Dallas Texas United States 75216
    79 Park Plaza Hosp Houston Texas United States 77004
    80 Houston Veterans Administration Med Ctr Houston Texas United States 77030
    81 Univ TX Health Science Ctr Houston Texas United States 77030
    82 Audie L Murphy Veterans Administration Hosp San Antonio Texas United States 78284
    83 Med Ctr of Vermont Hosp Burlington Vermont United States 05401
    84 Hampton Roads Med Specialists Hampton Virginia United States 23666
    85 Richmond AIDS Consortium Richmond Virginia United States 23219
    86 Univ of Washington Seattle Washington United States 98104
    87 Univ of Wisconsin Madison Wisconsin United States 53792
    88 UPR School of Medicine San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • Pharmacia and Upjohn

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002124
    Other Study ID Numbers:
    • 228B
    • M/3331/0021
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jul 1, 1997
    Keywords provided by , ,
    Drug Therapy, Combination
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Antiviral Agents
    Zidovudine
    Additional relevant MeSH terms:
    HIV Infections
    Lamivudine
    Zidovudine
    Delavirdine

    Study Results

    No Results Posted as of Jun 24, 2005