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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 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants.

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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.

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2012-04
Est. Completion 2014-09

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT01591252

The ClinicalTrials.gov registry entry for NCT01591252 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01591252 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.