Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001000
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
1999-11-02
Brief Title:
A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Immunologic Effect After Single Dose Atvogen in Healthy Volunteers and Asymptomatic HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2012-10
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 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
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
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 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 |
|---|---|---|---|
| 11030 | REGISTRY | DAIDS-ES | None |