Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007488
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2000-12-23
Brief Title:
HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2013-11
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 gain information on how the type and amount of HIV present in certain places in the body and in the blood are affected when potent powerful anti-HIV drugs are given
Researchers know that the type and amount of HIV may differ in certain places in the body called compartments but are not sure how anti-HIV treatment affects these differences This study gathers information to help understand how the virus grows and changes between blood and nonblood compartments in patients receiving anti-HIV treatment
Researchers know that the type and amount of HIV may differ in certain places in the body called compartments but are not sure how anti-HIV treatment affects these differences This study gathers information to help understand how the virus grows and changes between blood and nonblood compartments in patients receiving anti-HIV treatment
Detailed Description:
The goal of antiretroviral therapy is maximal suppression of HIV-1 replication Yet studies show that there is ongoing replication of latent virus in the blood and lymphoid tissues of some patients receiving potent antiretroviral therapy who have had suppressed plasma HIV-1 RNA levels for prolonged periods of time This continued viral persistence and replication could eventually result in virologic failure and clinical progression as well as selection and transmission of resistant HIV-1 There is a need to identify quantify and determine significance of viral reservoirs in compartments other than blood A5077 is designed to evaluate the relationship between viral load in blood and nonblood compartments and time to virologic failure in patients initiating or changing potent antiretroviral therapy
Patients contribute samples of blood at study entry prior to changing or initiating potent antiretroviral therapy Week 8 and every 8 weeks thereafter until Week 96 and if applicable within 30 days of confirmed virologic failure Samples of saliva and either genital secretions or lymphoid tissue or both are collected at study entry prior to changing or initiating potent antiretroviral therapy Weeks 16 48 and 96 and within 30 days of confirmed virologic failure Clinical assessments and medication updates are done at study visits Blood samples are tested for HIV-1 genotypic resistance studies HIV-1 proviral DNA studies and HIV-1 quantitation If total blood volumes exceed safe limits blood samples will not be drawn for A5077 but the A5077 protocol team will request access to plasma and PBMC samples from any coenrolled study if applicable
Patients contribute samples of blood at study entry prior to changing or initiating potent antiretroviral therapy Week 8 and every 8 weeks thereafter until Week 96 and if applicable within 30 days of confirmed virologic failure Samples of saliva and either genital secretions or lymphoid tissue or both are collected at study entry prior to changing or initiating potent antiretroviral therapy Weeks 16 48 and 96 and within 30 days of confirmed virologic failure Clinical assessments and medication updates are done at study visits Blood samples are tested for HIV-1 genotypic resistance studies HIV-1 proviral DNA studies and HIV-1 quantitation If total blood volumes exceed safe limits blood samples will not be drawn for A5077 but the A5077 protocol team will request access to plasma and PBMC samples from any coenrolled study if applicable
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 A5077 | None | None | None |
| AACTG A5077 | None | None | None |