Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01456962
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2011-10-06
Brief Title:
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Influence of Raltegravir-Containing Antiretroviral Therapy ART on Immune Reconstitution and Activation in the Female Genital Tract
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Increases in cluster of differentiation 4 CD4 T cells in the blood is well documented in human immunodeficiency virus HIV-infected individuals after starting antiretroviral therapy ART but increases CD4 T cells in the cervix is variable and not fully understood Although the amount of HIV in the vagina declines in parallel with those in the plasma when antiretroviral therapy for HIV is started HIV is still detected frequently in cervical samples from women with undetectable plasma viral loads suggesting that low level viral replication in the female vaginal tract could lead to both inflammation and incomplete increases in CD4 T cells Two classes of HIV medications nonnucleoside analogue reverse transcriptase inhibitors and protease inhibitors are substantially lower in the female genital tract compared to plasma whereas concentrations of another class nucleostide analogue reverse transcriptase inhibitors are similar or higher to those found in plasma Thus many widely used first-line three drug HIV therapies only achieve high concentrations of only two medications in the female genital tract Importantly with the recent development of raltegravir RAL which achieves concentrations in the female genital tract higher than those in plasma ART regimens that deliver high concentrations of 3 antiretroviral drugs to the female genital tract are now available The investigators hypothesize that cervical CD4 T cell reconstitution is better and inflammatory markers are lower in HIV-infected women on a HIV-therapy including tenofovir TDF and emtricitabine FTC with RAL versus ritonavir RIT-boosted atazanavir ATZ and that this is due to therapeutic concentrations of 3 versus 2 antiretroviral drugs in the female genital tract
Detailed Description:
None
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 |
|---|---|---|---|
| 39423 | OTHER_GRANT | Merck | None |