Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005572
Status:
COMPLETED
Last Update Posted:
2008-08-04
First Post:
2000-04-28
Brief Title:
A Comparison of HIV-Infected Patients With and Without Opportunistic AIDS-Related Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Study of Pathogen-Specific Immune Responses and General Immune Competence in Opportunistic Infections
Status:
COMPLETED
Status Verified Date:
2003-06
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 purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections Pneumocystis carinii pneumonia PCP cytomegalovirus CMV retinitis or CMV organ disease The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients This purpose reflects a change in the AIDS-related opportunistic infections studied Presently HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease This rationale reflects a change in the AIDS-related infections studied
Detailed Description:
To better understand the relationship between immunologic responses immune reconstitution and the occurrence of OIs observational data need to be collected 1 in patients who present with an OI before initiation of potent antiretroviral therapy 2 in patients with a history of such OIs who have had secondary prophylaxis or maintenance therapy withdrawn and do not develop OI recurrence after potent antiretroviral therapy and 3 in controls who were exposed to the pathogen of interest but never were at risk for disease because their immunity was not severely compromised Immunologic comparisons may identify correlates of protection for a group of patients who do not develop an OI after potent antiretroviral therapy-induced immune reconstitution Conversely a subpopulation of patients may be identified that lacks critical host factors of protection and is more likely to develop an OI after immune reconstitution and therefore would benefit from continued prophylaxis regardless of CD4 cell count
This study consists of 3 groups and 8 AS PER AMENDMENT 41701 6 subgroups Clinical microbiological data are collected and samples are obtained for immunologic assays pathogen-specific and general in all groups at entry time of OI presentation for Group 1 patients and at 12 weeks except Group 3b Group 1b patients also are evaluated at 24 weeks AS PER AMENDMENT 41701 The following text has been deleted and at the time of diagnosis of immune-recovery vitreitis if it should develop AS PER AMENDMENT 41701 Once patients in Groups 1 2 and 3a have completed the Week 12 evaluations they will be off-study Blood samples 1 to 7 days apart for peripheral blood mononuclear cells PBMCs LPA and inducible cytokine expression of interferon gamma interleukin-2 interleukin-4 and interleukin-10 are obtained
This study consists of 3 groups and 8 AS PER AMENDMENT 41701 6 subgroups Clinical microbiological data are collected and samples are obtained for immunologic assays pathogen-specific and general in all groups at entry time of OI presentation for Group 1 patients and at 12 weeks except Group 3b Group 1b patients also are evaluated at 24 weeks AS PER AMENDMENT 41701 The following text has been deleted and at the time of diagnosis of immune-recovery vitreitis if it should develop AS PER AMENDMENT 41701 Once patients in Groups 1 2 and 3a have completed the Week 12 evaluations they will be off-study Blood samples 1 to 7 days apart for peripheral blood mononuclear cells PBMCs LPA and inducible cytokine expression of interferon gamma interleukin-2 interleukin-4 and interleukin-10 are obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5067 | None | None | None |