A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Treatment of patients with HIV infection must address both the primary viral infection and the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the brain that may be useful in treating neurologic symptoms of HIV infection. The time course and degree of immunologic response to ampligen remain unknown although they are essential for proper use of the drug in the treatment of HIV...

Gender

MALE

Eligibility criteria

• • Inclusion Criteria
• • Patients' general good health should be determined by screening history, physical examination, and laboratory tests including CBC with differential, erythrocyte sedimentation rate, urinalysis, SMA-24, and drug screen within the established limits of normal for the hospital laboratory.
• • Exclusion Criteria
• Co-existing Condition:
• The following subjects will be excluded from the study:
• • Smokers.
• • Volunteers who have ingested alcohol 48 hours prior to the study.
• • Volunteers with clinically apparent viral disease or other illnesses, including allergies, within 2 weeks prior to the study or conditions which predispose them to chronic immune stimulation.
• Concurrent Medication:
• Excluded:
• • All medications.
• The following subjects will be excluded from the study:
• • Smokers.
• • Volunteers who have ingested alcohol 48 hours prior to the study.
• • Volunteers with clinically apparent viral disease or other illnesses, including allergies, within 2 weeks prior to the study or conditions which predispose them to chronic immune stimulation.
• Prior Medication:
• Excluded within 2 weeks of study entry:
• • All medications.
• • Recent history of drug or alcohol abuse.

Trial Officials