A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00002086
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
Stratogen of South Florida
🇺🇸Miami Beach, Florida, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Univ of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Univ of South Florida
🇺🇸Tampa, Florida, United States
ViRx Inc
🇺🇸San Francisco, California, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Vanderbilt School of Medicine
🇺🇸Nashville, Tennessee, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
North Shore Univ Hosp / Div of Infectious Diseases
🇺🇸Manhasset, New York, United States