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
Data Collection
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.560 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
AIDS Community Research Consortium
Redwood City, United StatesYale Univ / New Haven
New Haven, United StatesMed Ctr of Delaware / Wilmington Hosp
Wilmington, United States