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NCT01591252 · ClinicalTrials.gov registry record
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 200
- Enrollment target
NCT01591252: Completed study, sponsored by University of Alabama at Birmingham.
NCT01591252 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591252 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}). Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of ART, after excluding those subjects treated with tenofovir. BMD will decrease most significantly in HIV-positive subjects with the highest levels of cumulative viremia. HIV-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines. Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare sample and fracture association with the use of varying ART medications among dual-eligible persons in Medicare and Medicaid datasets. Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest duration of ART exposure.
Primary Outcome
Change in BMD after 1 year
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-09 |
What the finished NCT01591252 record still lists
NCT01591252 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01591252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591252 about?
NCT01591252 is a clinical study titled "Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)". In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (mea...
What is the current status of trial NCT01591252?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2012-04. Estimated completion is 2014-09.
Who is sponsoring clinical trial NCT01591252?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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