A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001000
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 20
- Expected to finish
- 1990-01-01
- Last updated by the study team
- 2012-10-19
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Hosp — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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