Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000713
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Clinical Trial To Evaluate the Toxicity Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Clinical Trial To Evaluate the Toxicity Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Individuals entered in the study are given ampligen by intravenous infusion once during the first week of the trial and twice a week during the following 8 weeks The dose each individual receives is determined by the responses of earlier individuals Each is followed for 12 weeks after the last dose of ampligen is given Each individual maintains a daily diary listing any symptoms or problems that occur such as headache nausea or change in appetite Other anti-HIV drugs cannot be taken during the trial and aspirin or acetaminophen should not be taken for more than 2 hours without consulting the research staff Blood is drawn at intervals during the trial and follow-up and used to determine the effect of ampligen on the HIV and the immune system as well as to monitor any toxicity and side effects
Individuals entered in the study are given ampligen by intravenous infusion once during the first week of the trial and twice a week during the following 8 weeks The dose each individual receives is determined by the responses of earlier individuals Each is followed for 12 weeks after the last dose of ampligen is given Each individual maintains a daily diary listing any symptoms or problems that occur such as headache nausea or change in appetite Other anti-HIV drugs cannot be taken during the trial and aspirin or acetaminophen should not be taken for more than 2 hours without consulting the research staff Blood is drawn at intervals during the trial and follow-up and used to determine the effect of ampligen on the HIV and the immune system as well as to monitor any toxicity and side effects
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11014 | REGISTRY | DAIDS ES Registry Number | None |