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

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

Sponsors

Lead sponsor: Hoffmann-La Roche

Source NIH AIDS Clinical Trials Information Service
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).

Overall Status Completed
Phase Phase 3
Study Type Interventional
Enrollment 528
Condition
Intervention

Intervention type: Drug

Intervention name: Zidovudine

Intervention type: Drug

Intervention name: Zalcitabine

Eligibility

Criteria:

Inclusion Criteria

Patients must have:

- HIV infection.

- CD4 count 100 - 500 cells/mm3.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Kaiser Foundation Hosp | Harbor City, California, 90710, United States
Kaiser Permanente Med Ctr | Los Angeles, California, 90027, United States
Sharp Rees - Stealy Med Group | San Diego, California, 92101, United States
UCSF - San Francisco Gen Hosp | San Francisco, California, 94110, United States
Denver Public Health Dept / Disease Control Services | Denver, Colorado, 80204, United States
Howard Univ | Washington, District of Columbia, 20060, United States
Veterans Administration Med Ctr | Washington, District of Columbia, 20422, United States
Miami Veterans Administration Med Ctr | Miami, Florida, 33125, United States
Univ of Miami School of Medicine | Miami, Florida, 33136, United States
Intergrated Care Ctr | Atlanta, Georgia, 30327, United States
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine | Wichita, Kansas, 67214, United States
New England Med Ctr | Boston, Massachusetts, 02111, United States
St Paul Ramsey Med Ctr / HIV Program Office | St. Paul, Minnesota, 55101, United States
Washington Univ | St. Louis, Missouri, 63110, United States
Univ of New Mexico School of Medicine | Albuquerque, New Mexico, 87131, United States
Bronx Veterans Affairs Med Ctr | Bronx, New York, 10468, United States
SUNY / Health Sciences Ctr at Brooklyn | Brooklyn, New York, 11203, United States
Saint Luke's - Roosevelt Hosp Ctr | New York, New York, 10019, United States
Ohio State Univ Hosp Clinic | Columbus, Ohio, 432101228, United States
Oregon Health Sciences Univ | Portland, Oregon, 97201, United States
N Texas Ctr for AIDS & Clin Rsch | Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch | Galveston, Texas, 775550882, United States
Dr Brian Buggy | Milwaukee, Wisconsin, 53215, United States
Location Countries

United States

Verification Date

February 1995

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Source: ClinicalTrials.gov