Clinical trial NCT00002117: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria

Patients must have:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Harbor City
country: United States
facility: Kaiser Foundation Hosp
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Diego
country: United States
facility: Sharp Rees - Stealy Med Group
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Denver
country: United States
facility: Denver Public Health Dept / Disease Control Services
state: Colorado
city: Washington
country: United States
facility: Howard Univ
state: District of Columbia
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Intergrated Care Ctr
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: St. Paul
country: United States
facility: St Paul Ramsey Med Ctr / HIV Program Office
state: Minnesota
city: St. Louis
country: United States
facility: Washington Univ
state: Missouri
city: Albuquerque
country: United States
facility: Univ of New Mexico School of Medicine
state: New Mexico
city: Bronx
country: United States
facility: Bronx Veterans Affairs Med Ctr
state: New York
city: Brooklyn
country: United States
facility: SUNY / Health Sciences Ctr at Brooklyn
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Dallas
country: United States
facility: N Texas Ctr for AIDS & Clin Rsch
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Milwaukee
country: United States
facility: Dr Brian Buggy
state: Wisconsin
Study officials:
References: