Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001080
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
Effect of Vaccination on Turnover of Lamivudine 3TC Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Vaccination on Turnover of Lamivudine 3TC Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
as of 42397
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents the activation of latently infected cells or an increase in cells permissive for replacing viral mutants
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known In particular it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1 or is due instead to activation of proviral sequences in previously resting CD4 cells One approach to discriminate these alternatives is a molecular pulse-chase experiment In this approach drug resistant mutants would be selected by administration of Lamivudine 3TC
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known In particular it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1 or is due instead to activation of proviral sequences in previously resting CD4 cells One approach to discriminate these alternatives is a molecular pulse-chase experiment In this approach drug resistant mutants would be selected by administration of Lamivudine 3TC
Detailed Description:
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known In particular it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1 or is due instead to activation of proviral sequences in previously resting CD4 cells One approach to discriminate these alternatives is a molecular pulse-chase experiment In this approach drug resistant mutants would be selected by administration of Lamivudine 3TC
Twenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks On day 14 half of the subjects will receive immunization with both the influenza and pneumococcal vaccine 3TC will be discontinued at this time Patients will be followed for 4 weeks after the immunization
Twenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks On day 14 half of the subjects will receive immunization with both the influenza and pneumococcal vaccine 3TC will be discontinued at this time Patients will be followed for 4 weeks after the immunization
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11311 | REGISTRY | DAIDS ES Registry Number | None |