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A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Zalcitabine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV infection. CD4 count 100 - 500 cells/mm3.

Sites / Locations

  • Kaiser Foundation Hosp
  • Kaiser Permanente Med Ctr
  • Sharp Rees - Stealy Med Group
  • UCSF - San Francisco Gen Hosp
  • Denver Public Health Dept / Disease Control Services
  • Howard Univ
  • Veterans Administration Med Ctr
  • Miami Veterans Administration Med Ctr
  • Univ of Miami School of Medicine
  • Intergrated Care Ctr
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Univ of Kansas School of Medicine
  • New England Med Ctr
  • St Paul Ramsey Med Ctr / HIV Program Office
  • Washington Univ
  • Univ of New Mexico School of Medicine
  • Bronx Veterans Affairs Med Ctr
  • SUNY / Health Sciences Ctr at Brooklyn
  • Saint Luke's - Roosevelt Hosp Ctr
  • Ohio State Univ Hosp Clinic
  • Oregon Health Sciences Univ
  • N Texas Ctr for AIDS & Clin Rsch
  • Univ TX Galveston Med Branch
  • Dr Brian Buggy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002117
Brief Title
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
Official Title
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 1995
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
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.
Detailed Description
Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
528 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection. CD4 count 100 - 500 cells/mm3.
Facility Information:
Facility Name
Kaiser Foundation Hosp
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Sharp Rees - Stealy Med Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver Public Health Dept / Disease Control Services
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Howard Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
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
Intergrated Care Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
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 Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
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
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Univ of New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Bronx Veterans Affairs Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
N Texas Ctr for AIDS & Clin Rsch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550882
Country
United States
Facility Name
Dr Brian Buggy
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection

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