search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Delavirdine mesylate
Didanosine
Sponsored by
Pharmacia and Upjohn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • East Bay AIDS Ctr
  • California Med Research Group
  • Los Angeles County - USC Med Ctr
  • Los Angeles County / Health Research Assoc / Drew Med Ctr
  • CARE Ctr / UCLA Med Ctr
  • UCI Med Ctr
  • AIDS Community Research Consortium
  • UCD Med Ctr / AIDS and Related Disorders Clinic
  • St Lukes Medical Group
  • UCSD / Ctr for Special Immunology
  • ViRx Inc
  • Saint Francis Mem Hosp
  • Davies Med Ctr
  • Shared Med Research Foundation
  • Harbor - UCLA Med Ctr
  • Univ Hosp / Univ of Colorado Health Sci Ctr
  • Georgetown Univ Med Ctr
  • George Washington Univ Med Ctr
  • Univ of Miami School of Medicine
  • Caremark Inc
  • Infectious Disease Research Institute Inc
  • Infectious Disease Rsch Consortium of GA / SE Clin Resources
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Univ of Illinois
  • Indiana Univ Infectious Disease Research Clinic
  • Univ of Iowa
  • Univ of Kansas School of Medicine / Univ Hosp
  • Univ of Kansas School of Medicine
  • Univ of Kentucky Med Ctr / Chandler Med Ctr
  • Tulane Univ Med School
  • AIDS Consultation Service / Maine Med Ctr
  • Univ of Maryland at Baltimore
  • Massachusetts Gen Hosp
  • Brigham and Women's Hosp
  • Boston City Hosp / FGH-1
  • New England Deaconess Hosp
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med Ctr
  • Univ of Michigan Hospitals and Health Ctrs
  • Harper Hosp
  • Henry Ford Hosp
  • St Paul Ramsey Med Ctr / HIV Program Office
  • Univ of Missouri at Kansas City School of Medicine
  • Washington Univ
  • Univ of Nebraska Med Ctr / HIV Clinic
  • Jersey Shore Med Ctr
  • Albany Med College
  • SUNY / Erie County Med Ctr at Buffalo
  • Community Research Initiative on AIDS
  • Beth Israel Med Ctr
  • Saint Vincent's Hosp and Med Ctr
  • New York Hosp - Cornell Med Ctr
  • Mount Sinai Med Ctr
  • Community Health Network
  • Univ of Rochester Med Ctr
  • SUNY / Health Sciences Ctr at Stony Brook
  • New York Med College / Westchester County Med Ctr
  • Univ of North Carolina School of Medicine
  • Carolinas Med Ctr
  • Duke Univ Med Ctr
  • Univ of Cincinnati / Holmes Hosp
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Pennsylvania State Univ / Hershey Med Ctr
  • Children's Hosp of Philadelphia
  • Univ of Pennsylvania / HIV Clinic
  • Buckley Braffman Stern Med Associates
  • Oncology and Hematology Association
  • Univ of Pittsburgh Med School
  • Mem Hosp of Rhode Island
  • Med Univ of South Carolina
  • Univ of Tennessee
  • Vanderbilt Univ
  • Central Texas Med Foundation
  • Dallas Veterans Administration Med Ctr
  • Park Plaza Hosp
  • Houston Veterans Administration Med Ctr
  • Univ TX Health Science Ctr
  • Univ TX San Antonio Health Science Ctr
  • Med Ctr of Vermont Hosp
  • Richmond AIDS Consortium
  • Univ of Washington
  • Univ of Wisconsin
  • UPR School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia and Upjohn
search

1. Study Identification

Unique Protocol Identification Number
NCT00002123
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacia and Upjohn

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Delavirdine mesylate
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
352942041
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
California Med Research Group
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Los Angeles County / Health Research Assoc / Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
CARE Ctr / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
UCD Med Ctr / AIDS and Related Disorders Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
St Lukes Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
UCSD / Ctr for Special Immunology
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Shared Med Research Foundation
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Univ Hosp / Univ of Colorado Health Sci Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Caremark Inc
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Infectious Disease Rsch Consortium of GA / SE Clin Resources
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Univ of Kansas School of Medicine / Univ Hosp
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
661607354
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Univ of Kentucky Med Ctr / Chandler Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
405360084
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
AIDS Consultation Service / Maine Med Ctr
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Univ of Maryland at Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston City Hosp / FGH-1
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Univ of Michigan Hospitals and Health Ctrs
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
481090378
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St Paul Ramsey Med Ctr / HIV Program Office
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Univ of Nebraska Med Ctr / HIV Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
Jersey Shore Med Ctr
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
122083479
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Community Research Initiative on AIDS
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
New York Med College / Westchester County Med Ctr
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ of Cincinnati / Holmes Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pennsylvania State Univ / Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Univ of Pennsylvania / HIV Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Oncology and Hematology Association
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Univ of Pittsburgh Med School
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Mem Hosp of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt Univ
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Dallas Veterans Administration Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Park Plaza Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Med Ctr of Vermont Hosp
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Univ of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
UPR School of Medicine
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs