Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006442
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2000-11-03
Brief Title:
The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Quantitative Assessment of Viral and Lymphocyte Dynamics in Blood and Lymphoreticular Tissues of HIV-1 Infected Patients Treated With Antiretroviral Agents
Status:
COMPLETED
Status Verified Date:
2005-01
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 examine the HIV virus in the blood and lymphoid tissues of patients taking anti-HIV medications
HIV infection is closely linked to the growth of the HIV virus in the body Much of this information was obtained from studying how the HIV virus grows in circulating blood Recent studies have shown that the lymphoid tissue part of the immune system is a major site where HIV is found in the body and is also where much of the HIV virus growth occurs This study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it
HIV infection is closely linked to the growth of the HIV virus in the body Much of this information was obtained from studying how the HIV virus grows in circulating blood Recent studies have shown that the lymphoid tissue part of the immune system is a major site where HIV is found in the body and is also where much of the HIV virus growth occurs This study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it
Detailed Description:
The natural history and pathogenesis of HIV-1 infection are linked closely to the replication of virus in the body Studies obtained entirely from analyses of peripheral blood led to a shift in the understanding of HIV-1 pathogenesis Recent studies have shown that lymphoid tissues are a major reservoir for HIV and the primary site of virus replication The proposed studies will provide the first comprehensive assessment of HIV-1 expression and lymphocyte response in both blood and lymphocyte tissue compartments The data obtained will provide new insight into HIV-1 pathogenesis and provide a more rational basis for treatment decisions concerning early therapy of HIV-1 infection
Patients are admitted to the hospital for insertion of an angiocath to collect blood samples periodically over 48 hours on the day study medication from the parent study is initiated After discharge additional blood samples are obtained over a 6-month period Within 7 days prior to a scheduled biopsy patients have physical examinations and laboratory evaluations done All patients undergo some combination of the following during the 2-week prestudy evaluation period and at Weeks 4 and 24 a superficial lymph node biopsy from cervical axillary or inguinal area b rectal biopsy andor c tonsillar biopsy The tissue samples provide an assessment of viral and cellular dynamics
Patients are admitted to the hospital for insertion of an angiocath to collect blood samples periodically over 48 hours on the day study medication from the parent study is initiated After discharge additional blood samples are obtained over a 6-month period Within 7 days prior to a scheduled biopsy patients have physical examinations and laboratory evaluations done All patients undergo some combination of the following during the 2-week prestudy evaluation period and at Weeks 4 and 24 a superficial lymph node biopsy from cervical axillary or inguinal area b rectal biopsy andor c tonsillar biopsy The tissue samples provide an assessment of viral and cellular dynamics
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 |
|---|---|---|---|
| UABPHA100R | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AI035467 |
| R01AI035467 | NIH | None | None |