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

Study Overview
=================
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.

Official Title
-----------------
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

Intervention / Treatment
-----------------
* Drug: Interferon alfa-n3
* Drug: Interferon alfa-n1


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon alfa-n3|nan|
|Drug: Interferon alfa-n1|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interferon-alpha, Drug Therapy, Combination, Adjuvants, Immunologic, Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex