Viewing Study NCT00086372



Ignite Creation Date: 2024-05-05 @ 11:34 AM
Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00086372
Status: COMPLETED
Last Update Posted: 2012-10-29
First Post: 2004-06-30

Brief Title: Long-term Follow-up of HIV Infected Patients Identified During Early Infection
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Acute HIV Infection and Early Disease Research Program AIEDRP CORE01 Database
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: 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
Detailed Description: AIEDRP was established to develop and evaluate data from studies of patients with acute or recent HIV infection Long-term effects of antiretroviral therapies raise questions regarding the value and necessity of therapeutic interventions during acute and early HIV infection Conventional randomized clinical trials are generally designed with finite endpoints most patients who reach an endpoint or complete a protocol are no longer followed As a result long-term virologic immunologic and clinical outcome data are not available This is particularly true for participants who fail therapy require changes in treatment or develop a treatment-limiting toxicity in a time-limited study

This database study will establish a cohort of HIV infected individuals who are participating in HIV studies at AIEDRP sites and of HIV infected individuals who have chosen to defer therapy but agree to be followed by this study The study will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of AIEDRP studies by developing data collection guidelines defining common research goals and creating data templates The primary aim is to determine the long-term virologic immunologic and clinical outcomes and complications for patients who were diagnosed during acute or early HIV infection

Participants in this study will be followed for at least 5 years Study visits will occur at Weeks 2 4 and 12 and then every 12 weeks thereafter through Week 96 After 2 years study visits will occur every 24 weeks until the end of the study Participants who start antiretroviral therapy at or after Week 2 will restart the study visit schedule Study visits will include a medical interview adherence questionnaire and blood tests Duplicate tests performed as part of another study will not be performed if the results of those tests are available

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
ACTG A5228 None None None