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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001000

Purpose

To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to certain infections after a single dose of atvogen (ampligen). In addition, the relationship between activation of immune cells and biochemical markers of that activation will be studied.

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 infection and perhaps other clinical problems.

Condition	Intervention
HIV Infections	Drug: Ampligen

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Ampligen

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

20

Detailed Description:

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 infection and perhaps other clinical problems.

Ten healthy volunteers and 10 HIV-infected patients are randomized between ampligen or placebo group. Five volunteers in each group receive a single dose of ampligen on day 1 and a single dose of placebo on day 8. The other 5 volunteers receive the drug and placebo on day 8 and 1, respectively. Seven days of observation and testing follow each administration of drug or placebo and also allow the body to eliminate the drug.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001000

Locations

United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

PS Lietman

More Information

Publications:

Hendrix CW, Margolick JB, Petty BG, Markham RB, Nerhood L, Farzadegan H, Ts'o PO, Lietman PS. Biologic effects after a single dose of poly(I):poly(C12U) in healthy volunteers. Antimicrob Agents Chemother. 1993 Mar;37(3):429-35.

Study ID Numbers:	ACTG 056
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001000 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Macrophage Activation
Lymphocyte Transformation
Immunologic Surveillance
ampligen
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Ampligen
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009