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NCT00000713 · ClinicalTrials.gov registry record · Phase 1
A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00000713 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants.
The verdict
NCT00000713, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied. Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to stimulate the immune system of the individual or both. The immune system is the means the human body has for fighting infections. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit HIV in vitro (test tube) at drug levels that can be achieved without noticeable clinical side effects.
Interventions
- DRUG Ampligen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Est. Completion | 1992-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000713
The ClinicalTrials.gov registry entry for NCT00000713 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ampligen is the first listed.
NCT00000713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000713 about?
NCT00000713 is a clinical study titled "A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects". To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will be studied. Evidence indicates that a long period with no symptoms follows infection with HIV. Indi...
What is the current status of trial NCT00000713?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. Estimated completion is 1992-10.
What interventions are being tested in trial NCT00000713?
The interventions under investigation include: Ampligen (DRUG).
Who is sponsoring clinical trial NCT00000713?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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