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NCT00002117 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002117
Other study ID # 220A
Secondary ID NV 14257
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date February 1995
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 528
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

Patients must have:

- HIV infection.

- CD4 count 100 - 500 cells/mm3.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zidovudine

• Zalcitabine

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

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

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