Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to \>= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only. Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
256
ViRx Inc
San Francisco, California, United States
Marin County Specialty Clinic
San Rafael, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Stratogen of South Florida
Miami Beach, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
...and 3 more locations
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