Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001093
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
1999-11-02
Brief Title:
Outcomes of Anti-HIV Therapy During Early HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Outcomes of Antiretroviral Therapy During Primary HIV Infection
Status:
COMPLETED
Status Verified Date:
2012-10
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 find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV
Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible However early HIV infection is not yet completely understood so it is not known if this is the best approach This study will look at the effects of beginning anti-HIV treatment during early HIV infection
Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible However early HIV infection is not yet completely understood so it is not known if this is the best approach This study will look at the effects of beginning anti-HIV treatment during early HIV infection
Detailed Description:
Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs the tolerability and efficacy of this approach has not been systemically evaluated Many features of primary HIV pathogenesis are incompletely understood A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection
Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols An untreated cohort of 12 patients is also followed on this study Patients are stratified at enrollment according to their stage of acute or early HIV infection Patients are evaluated for virologic immunologic and clinical parameters for 96 weeks In addition novel studies of source partner identification are proposed An effort is made to determine the most likely source partners for each study patient on the basis of patient recall of possible exposures A separate study protocol will evaluate the source partner
Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols An untreated cohort of 12 patients is also followed on this study Patients are stratified at enrollment according to their stage of acute or early HIV infection Patients are evaluated for virologic immunologic and clinical parameters for 96 weeks In addition novel studies of source partner identification are proposed An effort is made to determine the most likely source partners for each study patient on the basis of patient recall of possible exposures A separate study protocol will evaluate the source partner
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 |
|---|---|---|---|
| AIEDRP AI-05-005 | None | None | None |
| AEHIV 005 | None | None | None |