HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon-alpha
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.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * Symptomatic HIV infection. * CD4 count 50 - 350 cells/mm3. Prior Medication: Allowed: * Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry). * Maintenance therapy for a chronic condition.
Exclusion criteria
Patients with the following prior condition are excluded: * Change in antiretroviral therapy within past 6 weeks. Prior Medication: Excluded: * Oral IFN-alpha or other immune-based therapy within the past month. * Therapy for any acute disease within the past week.
Countries
United States
Outcome results
None listed