Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002297
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Isoprinosine in Patients With Lymph Node Disease
Sponsor:
Newport Pharmaceuticals International
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine Inosiplex in Patients With Unexplained Generalized Lymphadenopathy
Status:
COMPLETED
Status Verified Date:
1989-06
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:
The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy Variables to be examined will include
Signs and symptoms
Lymphadenopathy
Fever
Weight loss
Occurrence of opportunistic infections
Cell-mediated immune system parameters
T-helper cell OKT4 numbers and proportions
T-suppressor cell OKT8 numbers and proportions
Natural killer NK cell activity
Lymphocyte blastogenic response to phytohemagglutinin PHA
Lymphocyte blastogenic response to pokeweed mitogen PWM
Immunoglobulin IgG IgA IgM IgE IgD profile
Circulating immune complexes Infections characteristically associated with AIDS such as Candida albicans Pneumocystis carinii pneumonia Cytomegalovirus Herpes simplex Cryptococcus Histoplasma Toxoplasma Cryptosporidium Mycobacterium avium- intracellulare Legionella and Isospora
Safety parameters
Blood chemistry including serum uric acid PurposeA-12
Complete blood count CBC
Platelet count
Signs and symptoms
Lymphadenopathy
Fever
Weight loss
Occurrence of opportunistic infections
Cell-mediated immune system parameters
T-helper cell OKT4 numbers and proportions
T-suppressor cell OKT8 numbers and proportions
Natural killer NK cell activity
Lymphocyte blastogenic response to phytohemagglutinin PHA
Lymphocyte blastogenic response to pokeweed mitogen PWM
Immunoglobulin IgG IgA IgM IgE IgD profile
Circulating immune complexes Infections characteristically associated with AIDS such as Candida albicans Pneumocystis carinii pneumonia Cytomegalovirus Herpes simplex Cryptococcus Histoplasma Toxoplasma Cryptosporidium Mycobacterium avium- intracellulare Legionella and Isospora
Safety parameters
Blood chemistry including serum uric acid PurposeA-12
Complete blood count CBC
Platelet count
Detailed Description:
None
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 |
|---|---|---|---|
| ISO-103-USA | None | None | None |