Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000930
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-11-02
Brief Title:
A Study of HIV in Newly Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Infected Participants Protocol Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
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 see how HIV reacts in the immune systems of patients who have recently been infected with HIV This study also examines HIVs resistance to anti-HIV drugs in newly infected patients
Certain populations are good candidates for participation in HIV vaccine trials These groups include men who have sex with men IV drug users and women at risk of getting HIV through heterosexual contact Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies
Certain populations are good candidates for participation in HIV vaccine trials These groups include men who have sex with men IV drug users and women at risk of getting HIV through heterosexual contact Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies
Detailed Description:
This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials The detection of changes in HIV phenotype and genotype clinical progression rates and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials
This study consists of two parts Part A includes HIV-infected patients who enrolled in HIVNET D011 infected-participants cohort of HIVNET D01 and whose HIV disease has been closely monitored and characterized This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter Part B includes newly HIV-infected patients These patients are monitored with clinical and laboratory evaluations at 0 1 3 6 9 12 and 18 months and then every 6 months through Year 5
This study consists of two parts Part A includes HIV-infected patients who enrolled in HIVNET D011 infected-participants cohort of HIVNET D01 and whose HIV disease has been closely monitored and characterized This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter Part B includes newly HIV-infected patients These patients are monitored with clinical and laboratory evaluations at 0 1 3 6 9 12 and 18 months and then every 6 months through Year 5
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