Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053404
Status:
UNKNOWN
Last Update Posted:
2008-09-26
First Post:
2003-01-28
Brief Title:
Immunologic Control of Drug Resistant HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Observational Study of HIV Infected Adults With Detectable Plasma HIV-1 RNA Levels Between 200 and 10000 CopiesmL While Receiving Stable Antiretroviral Therapy
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time However these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood This study will explore why some patients with drug resistant virus continue to have low viral loads
Detailed Description:
Despite the emergence of high level drug resistance in HIV-infected patients on stable antiretroviral therapy plasma HIV RNA levels generally remain below the pretherapy viral load set-point The virologic and immunologic determinants of this lower steady state level of viremia have not been defined Preliminary data indicate that 1 drug resistant variants have reduced replicative capacity and pathogenic potential 2 drug resistant viremia is associated with reduced T cell activation and turnover compared to wild-type viremia and 3 patients with low level drug resistant viremia often have HIV-specific CD4 cells that are absent in patients with higher levels of viremia This study will investigate whether the emergence of a poorly fit drug resistant variant results in the generation of an effective HIV-specific CD4 cell response and if this response contributes to the establishment of a lower steady state level of viremia
Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued Study visits will occur every 2 months for a total of 14 visits Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load viral replicative capacity drug resistance phenotype T cell turnover and thymic function
Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued Study visits will occur every 2 months for a total of 14 visits Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load viral replicative capacity drug resistance phenotype T cell turnover and thymic function
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 |
|---|---|---|---|
| 1R01AI052745-01 | NIH | None | httpsreporternihgovquickSearch1R01AI052745-01 |