Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006144
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-08-07
Brief Title:
A Study of HIV-Disease Development in Aging
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging
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:
The purpose of this study is to better understand the relationship between age and HIV disease progression
This study will explore the possible relationship between age and HIV disease progression Older age is an important risk factor for faster disease development but older people may respond better to combination drug therapy This relationship needs to be understood better
This study will explore the possible relationship between age and HIV disease progression Older age is an important risk factor for faster disease development but older people may respond better to combination drug therapy This relationship needs to be understood better
Detailed Description:
Older age is an important risk factor for accelerated HIV-disease progression However the virologic response to highly active antiretroviral therapy HAART may be superior in older persons A better understanding of the immunologic virologic and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease
Patients are grouped according to age Group A consists of patients between the ages of 13 and 30 years Group B consists of patients age 45 years or older All patients receive open-label lopinavirritonavir LPVRTV plus emtricitabine FTC plus stavudine d4T for 96 AS PER AMENDMENT 060402 192 weeks Study visits occur at pre-entry entry and Weeks 4 8 12 16 and 24 then every 12 weeks thereafter through Week 96 AS PER AMENDMENT 060402 Week 192 Clinical assessments safety laboratory tests CD4 cell count monitoring lymphocyte phenotyping and HIV-1 RNA determinations are performed routinely Blood samples are stored for further immunology and virology studies Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s AS PER AMENDMENT 060402 Substudy A5017s has been eliminated
Patients are grouped according to age Group A consists of patients between the ages of 13 and 30 years Group B consists of patients age 45 years or older All patients receive open-label lopinavirritonavir LPVRTV plus emtricitabine FTC plus stavudine d4T for 96 AS PER AMENDMENT 060402 192 weeks Study visits occur at pre-entry entry and Weeks 4 8 12 16 and 24 then every 12 weeks thereafter through Week 96 AS PER AMENDMENT 060402 Week 192 Clinical assessments safety laboratory tests CD4 cell count monitoring lymphocyte phenotyping and HIV-1 RNA determinations are performed routinely Blood samples are stored for further immunology and virology studies Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s AS PER AMENDMENT 060402 Substudy A5017s has been eliminated
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 |
|---|---|---|---|
| Substudy ACTG A5020s | Registry Identifier | DAIDS ES | None |
| 10168 | REGISTRY | None | None |
| ACTG A5015 | None | None | None |
| AACTG A5015 | None | None | None |
| Substudy ACTG A5016s | None | None | None |