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

Condition(s) targeted: HIV Infections

Intervention: Zidovudine (Drug); Zalcitabine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy 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 design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Patients must have:

- HIV infection.

- CD4 count 100 - 500 cells/mm3.

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

Last updated: June 23, 2005