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A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects

NCT00215852 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-09-04

No results posted yet for this study

Summary

To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels.

Conditions

  • HIV Infections

Interventions

DRUG

Alferon LDO

500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle.

Sponsors & Collaborators

Principal Investigators

  • David R Strayer, MD · AIM ImmunoTech Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215852 on ClinicalTrials.gov