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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002124
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  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 Intervention Phase
HIV Infections
Drug: Delavirdine mesylate
Drug: Lamivudine
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 1250
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002124

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 352942041
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Peachwood Med Ctr
Clovis, California, United States, 93612
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 900331079
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States, 90059
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States, 90095
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
UCI Med Ctr
Orange, California, United States, 92668
AIDS Community Research Consortium
Redwood City, California, United States, 94063
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, United States, 95817
St Lukes Medical Group
San Diego, California, United States, 92101
UCSD / Ctr for Special Immunology
San Diego, California, United States, 92103
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
ViRx Inc
San Francisco, California, United States, 94103
Davies Med Ctr
San Francisco, California, United States, 94114
Shared Med Research Foundation
Tarzana, California, United States, 91356
Harbor - UCLA Med Ctr
Torrance, California, United States, 90509
United States, Colorado
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Caremark Inc
Palm Beach Gardens, Florida, United States, 33410
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
United States, Georgia
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, United States, 30345
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Univ of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
United States, Iowa
Univ of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, United States, 661607354
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Kentucky
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, United States, 405360084
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
United States, Maine
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212052196
Univ of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston City Hosp / FGH-1
Boston, Massachusetts, United States, 02118
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Michigan
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, United States, 481090378
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Harper Hosp
Detroit, Michigan, United States, 48201
United States, Minnesota
St Paul Ramsey Med Ctr / HIV Program Office
St. Paul, Minnesota, United States, 55101
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Washington Univ
St. Louis, Missouri, United States, 63110
United States, Nebraska
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States, 681985130
United States, New Jersey
Jersey Shore Med Ctr
Neptune, New Jersey, United States, 07753
United States, New York
Albany Med College
Albany, New York, United States, 122083479
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Mount Sinai Med Ctr
New York, New York, United States, 10029
Beth Israel Med Ctr
New York, New York, United States, 10003
New York Hosp - Cornell Med Ctr
New York, New York, United States, 10021
Community Research Initiative on AIDS
New York, New York, United States, 10001
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Community Health Network
Rochester, New York, United States, 14620
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States, 117948153
New York Med College / Westchester County Med Ctr
Valhalla, New York, United States, 10595
United States, North Carolina
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 275997215
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28204
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, United States, 45267
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Univ of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, United States, 17033
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States, 19104
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Oncology and Hematology Association
Philadelphia, Pennsylvania, United States, 19146
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Stratogen Health / Independent Research Nurses
Cranston, Rhode Island, United States, 02910
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
Vanderbilt Univ
Nashville, Tennessee, United States, 37212
United States, Texas
Central Texas Med Foundation
Austin, Texas, United States, 78751
Dallas Veterans Administration Med Ctr
Dallas, Texas, United States, 75216
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Univ TX Health Science Ctr
Houston, Texas, United States, 77030
Park Plaza Hosp
Houston, Texas, United States, 77004
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United States, Vermont
Med Ctr of Vermont Hosp
Burlington, Vermont, United States, 05401
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Richmond AIDS Consortium
Richmond, Virginia, United States, 23219
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
United States, Wisconsin
Univ of Wisconsin
Madison, Wisconsin, United States, 53792
Puerto Rico
UPR School of Medicine
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Pharmacia and Upjohn
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002124     History of Changes
Other Study ID Numbers: 228B, M/3331/0021
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Delavirdine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 19, 2014