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

This study has been completed.
Study NCT00001000.   Last updated on June 23, 2005.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
Official Title  Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients
Brief Summary

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.

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Double-Blind
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Ampligen
MEDLINE PMIDs 7681656
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  20
Start Date 
Completion Date
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.

Gender Male
Ages 18 Years to 45 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001000
Organization ID ACTG 056
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     PS Lietman        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 1991
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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