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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Interferon alfa-n3; Drug: Interferon alfa-n1

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000844

11727 (Registry Identifier)

DATRI 022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.