Back to resultsA Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ampligen
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Macrophage Activation, Lymphocyte Transformation, Immunologic Surveillance, ampligen, Antiviral Agents
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.
Sites / Locations
- Johns Hopkins Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001000
First Posted
November 2, 1999
Last Updated
October 18, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00001000
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1990 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Macrophage Activation, Lymphocyte Transformation, Immunologic Surveillance, ampligen, Antiviral Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ampligen
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PS Lietman
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7681656
Citation
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. doi: 10.1128/AAC.37.3.429.
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A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
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