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 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

October 25, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000844 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Interferon alfa-n3
Drug: Interferon alfa-n1

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

560

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000844

Responsible Party

Study ID Numbers ^ICMJE

DATRI 022

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Alston B
Study Chair:	Standiford H
Study Chair:	Kumi J
Study Chair:	Greaves W

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

November 1998

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP