A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3
- Conditions
- HIV Infections
- Registration Number
- NCT00000844
- Brief Summary
To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
- Detailed Description
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
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 (15)
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Yale Univ / New Haven
🇺🇸New Haven, Connecticut, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
King - Drew Med Ctr
🇺🇸Los Angeles, California, United States
Med Ctr of Delaware / Wilmington Hosp
🇺🇸Wilmington, Delaware, United States
Abundant Life Clinic Foundation
🇺🇸Washington, District of Columbia, United States
Dr Barbara Justice
🇺🇸New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
SUNY / Health Sciences Ctr at Brooklyn
🇺🇸Brooklyn, New York, United States
New York Med College / Westchester County Med Ctr
🇺🇸Valhalla, New York, United States
Meharry Med College
🇺🇸Nashville, Tennessee, United States
Univ of Minnesota Hosp
🇺🇸Minneapolis, Minnesota, United States
Univ of Pennsylvania Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States