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NCT01456962 · ClinicalTrials.gov registry record
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract
A clinical trial of HIV Infection and Women's Health, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 36
- Enrollment target
- 1
- Study location
NCT01456962: Completed study of HIV Infection and Women's Health, sponsored by University of Colorado, Denver.
NCT01456962 is a study of HIV Infection and Women's Health that has completed, run by University of Colorado, Denver. The registered enrollment target is 36 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456962, a study of HIV Infection and Women's Health, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
- 1
- Study location
Study 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, nucleos(t)ide 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.
Primary Outcome
Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.
Conditions Studied
Study Locations (1)
Colorado
- University of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-08 |
What the finished NCT01456962 record still lists
NCT01456962 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with HIV Infection appearing as the primary indexed condition, and to 0 interventions.
NCT01456962 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01456962 about?
NCT01456962 is a clinical study titled "Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract". 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 i...
What is the current status of trial NCT01456962?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2011-10. Estimated completion is 2013-08.
What conditions does trial NCT01456962 study?
This clinical trial studies the following conditions: HIV Infection, Women's Health, Genital Diseases, Female.
Who is sponsoring clinical trial NCT01456962?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01456962 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01456962's enrollment target sits among peer trials
36 49th of 73 higher than 22 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
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