To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Zidovudine  Drug: Zalcitabine	Phase III

Further Study Details: 

Expected Total Enrollment:  528

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV infection.
• CD4 count 100 - 500 cells/mm3.

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

Study ID Numbers:  220A; NV 14257
Record last reviewed:  February 1995
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002117
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08