A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002123
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1996
  Purpose

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 Intervention Phase
HIV Infections
Drug: Delavirdine mesylate
Drug: Didanosine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002123

  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
California Med Research Group
Fresno, California, United States, 93726
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
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
UCSD / Ctr for Special Immunology
San Diego, California, United States, 92103
St Lukes Medical Group
San Diego, California, United States, 92101
ViRx Inc
San Francisco, California, United States, 94103
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
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
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
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
Univ of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
Boston City Hosp / FGH-1
Boston, Massachusetts, United States, 02118
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
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
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Oncology and Hematology Association
Philadelphia, Pennsylvania, United States, 19146
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
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
Univ TX Health Science Ctr
Houston, Texas, United States, 77030
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Park Plaza Hosp
Houston, Texas, United States, 77004
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
United States, Vermont
Med Ctr of Vermont Hosp
Burlington, Vermont, United States, 05401
United States, Virginia
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

Publications:
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Cox SR, Edge-Padbury BA, Carberry PA, Wathen LK. Delavirdine (DLV) + didanosine (ddI) combination therapy has sustained surrogate marker response in advanced HIV-1 population. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163

ClinicalTrials.gov Identifier: NCT00002123     History of Changes
Other Study ID Numbers: 228A, M/3331/0017
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:
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

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
Didanosine
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 April 17, 2014