Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006415
Status:
WITHDRAWN
Last Update Posted:
2015-03-09
First Post:
2000-10-19
Brief Title:
A Study of Patients Who Recently Have Been Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Subjects With Primary or Early Human Immunodeficiency Virus HIV Infection
Status:
WITHDRAWN
Status Verified Date:
2015-03
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 find out if anti-HIV drugs taken by patients who are newly infected with HIV can make the level of HIV in the body too low to detect
Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients Approved anti-HIV drugs can reduce the amount of HIV but more research needs to be done in newly infected patients This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV
Studying patients who recently have been infected with HIV may help researchers understand how HIV infection works and how anti-HIV drugs may help these patients Approved anti-HIV drugs can reduce the amount of HIV but more research needs to be done in newly infected patients This study will look at recently HIV-infected patients to study the progression of HIV disease and to see whether anti-HIV drugs can reduce the level of HIV
Detailed Description:
Primary and early HIV infection represents a potentially unique opportunity to better understand the pathogenesis of HIV infection as well as to potentially prevent the establishment of latent infection Approved antiretroviral therapy is able to reduce plasma viremia to unmeasurable levels in established infection and several groups have observed comparable effects in recently infected adults This study is designed to evaluate and follow a cohort of patients with primary or early HIV infection and to evaluate the time course of latent infection and whether latent infection in CD4 cells will allow viral persistence despite antiretroviral therapy
Patients begin antiretroviral therapy within 7 days of enrollment All patients are evaluated for treatment compliance and complete a compliance questionnaire regularly Clinical evaluations including CD4 CD8 and HIV RNA counts also are done regularly Antiretroviral therapy is discontinued if there is no detectable virus by ultrasensitive assay and culture techniques in plasma PBMCs and lymphoid tissue In a subset of patients genital secretions and CSF cerebrospinal fluid are evaluated If relapse occurs antiretroviral therapy is re-instituted In addition virology and immunology substudies are performed
Patients begin antiretroviral therapy within 7 days of enrollment All patients are evaluated for treatment compliance and complete a compliance questionnaire regularly Clinical evaluations including CD4 CD8 and HIV RNA counts also are done regularly Antiretroviral therapy is discontinued if there is no detectable virus by ultrasensitive assay and culture techniques in plasma PBMCs and lymphoid tissue In a subset of patients genital secretions and CSF cerebrospinal fluid are evaluated If relapse occurs antiretroviral therapy is re-instituted In addition virology and immunology substudies are performed
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 |
|---|---|---|---|
| ACRU 010 | None | None | None |