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
NCT ID: NCT00002124
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1250 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Delavirdine mesylate
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
14 Years
ALL
No
Sponsors
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Pharmacia and Upjohn
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
East Bay AIDS Ctr
Berkeley, California, United States
Peachwood Med Ctr
Clovis, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States
UCI Med Ctr
Orange, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, United States
St Lukes Medical Group
San Diego, California, United States
UCSD / Ctr for Special Immunology
San Diego, California, United States
ViRx Inc
San Francisco, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
Davies Med Ctr
San Francisco, California, United States
Shared Med Research Foundation
Tarzana, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Caremark Inc
Palm Beach Gardens, Florida, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Univ of Illinois
Chicago, Illinois, United States
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Univ of Iowa
Iowa City, Iowa, United States
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, United States
Univ of Maryland at Baltimore
Baltimore, Maryland, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Massachusetts Gen Hosp
Boston, Massachusetts, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
Boston City Hosp / FGH-1
Boston, Massachusetts, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, United States
Harper Hosp
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
St Paul Ramsey Med Ctr / HIV Program Office
Saint Paul, Minnesota, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Washington Univ
St Louis, Missouri, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States
Jersey Shore Med Ctr
Neptune City, New Jersey, United States
Albany Med College
Albany, New York, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Community Research Initiative on AIDS
New York, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
New York Hosp - Cornell Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Community Health Network
Rochester, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States
Univ of Oklahoma
Oklahoma City, Oklahoma, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Oncology and Hematology Association
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Stratogen Health / Independent Research Nurses
Cranston, Rhode Island, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Univ of Tennessee
Memphis, Tennessee, United States
Vanderbilt Univ
Nashville, Tennessee, United States
Central Texas Med Foundation
Austin, Texas, United States
Dallas Veterans Administration Med Ctr
Dallas, Texas, United States
Park Plaza Hosp
Houston, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Med Ctr of Vermont Hosp
Burlington, Vermont, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Univ of Washington
Seattle, Washington, United States
Univ of Wisconsin
Madison, Wisconsin, United States
UPR School of Medicine
San Juan, , Puerto Rico
Countries
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Other Identifiers
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M/3331/0021
Identifier Type: -
Identifier Source: secondary_id
228B
Identifier Type: -
Identifier Source: org_study_id