Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103961
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2005-02-17
Brief Title:
An Observational Study of People Who Have Recently 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:
Primary HIV Early Disease Research American Cohort PHAEDRA AIEDRP
Status:
COMPLETED
Status Verified Date:
2008-09
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:
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program AIEDRP The purpose of this study is to collect data on the immunological and virologic responses that occur early in the course of HIV infection in treatment-naive and treatment-experienced HIV infected adults
Study hypothesis This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression In addition this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function Furthermore this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission
Study hypothesis This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression In addition this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function Furthermore this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission
Detailed Description:
This study will collect data on the immunological and virologic responses that occur early in the course of HIV infection in treated and untreated HIV infected adults to identify host immunological virological and therapeutic factors that influence disease progression This study will also monitor changing patterns in the transmission of drug-resistant viral strains and evaluate ongoing behavioral risk factors associated with HIV infection
Participants in this study will be followed for up to 10 years During the first year of participation study visits will occur approximately every 4 weeks for the first 12 weeks then every 12 weeks thereafter with a minimum of 8 study visits during the first year Participants will be asked to complete a behavioral questionnaire at Week 8 After the first year of participation there will be 4 visits per year Blood collection and vital sign measurement will occur at each study visit
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study
Participants in this study will be followed for up to 10 years During the first year of participation study visits will occur approximately every 4 weeks for the first 12 weeks then every 12 weeks thereafter with a minimum of 8 study visits during the first year Participants will be asked to complete a behavioral questionnaire at Week 8 After the first year of participation there will be 4 visits per year Blood collection and vital sign measurement will occur at each study visit
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study
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 |
|---|---|---|---|
| 5U01AI052403 | NIH | None | httpsreporternihgovquickSearch5U01AI052403 |
| 2003-P-001991 | None | None | None |