skip to content

Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


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

First received: November 2, 1999
Last updated: October 18, 2012
Last Verified: October 2012
History of Changes
Purpose

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: Masking: Double
Primary Purpose: Treatment
Official Title: Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients

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

Enrollment: 20
Study Completion Date: January 1990

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

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00001000   History of Changes  
Other Study ID Numbers: ACTG 056  
  11030  
Study First Received: November 2, 1999  
Last Updated: October 18, 2012  

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

Macrophage Activation
Lymphocyte Transformation
Immunologic Surveillance
ampligen
Antiviral Agents

Additional relevant MeSH terms:
Infection
HIV Infections
poly(I).poly(c12,U)

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.