Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001012
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of AL721 in HIV-Infected Patients With Swollen Lymph Nodes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open Label Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection
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 study the tolerance and safety of increasing doses of AL-721 in patients with persistent generalized lymphadenopathy PGL and symptomatic HIV infection and to obtain preliminary information on the effectiveness of AL-721 against the human immunodeficiency virus HIV in HIV-infected persons with PGL and symptomatic HIV infection Although zidovudine AZT prolongs life in certain AIDS patients it is not a cure for AIDS and it also has toxic effects in many patients Therefore it is necessary to test other drugs in HIV-infected patients AL-721 is a mixture of lipids fats extracted from egg yolks Laboratory tests suggest that it might inhibit the infectivity of the HIV AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated
Detailed Description:
Although zidovudine AZT prolongs life in certain AIDS patients it is not a cure for AIDS and it also has toxic effects in many patients Therefore it is necessary to test other drugs in HIV-infected patients AL-721 is a mixture of lipids fats extracted from egg yolks Laboratory tests suggest that it might inhibit the infectivity of the HIV AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated
Patients receive AL-721 twice daily The first dose is taken on an empty stomach 1 hour before a fat-free breakfast with specific instructions given on foods that are allowed the second dose is taken at least 3 hours after the evening meal No snacks are permitted after the evening meal or after the evening dose of study medication The study is scheduled to last for 16 weeks of treatment and 4 weeks of follow-up Throughout the study frequent blood samples will be taken from an arm vein The blood samples are studied to evaluate any changes in the patients immune system any toxic effects that might be detected in the blood and any changes in the presence of the HIV in the blood
Patients receive AL-721 twice daily The first dose is taken on an empty stomach 1 hour before a fat-free breakfast with specific instructions given on foods that are allowed the second dose is taken at least 3 hours after the evening meal No snacks are permitted after the evening meal or after the evening dose of study medication The study is scheduled to last for 16 weeks of treatment and 4 weeks of follow-up Throughout the study frequent blood samples will be taken from an arm vein The blood samples are studied to evaluate any changes in the patients immune system any toxic effects that might be detected in the blood and any changes in the presence of the HIV in the blood
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?: