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NCT01378494 · ClinicalTrials.gov registry record

Bone Mineral Density in HIV+ Patients

A clinical trial, sponsored by University of Alabama at Birmingham.

Completed
Registry status
200
Enrollment target

NCT01378494: Completed study, sponsored by University of Alabama at Birmingham.

NCT01378494 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.

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The verdict

NCT01378494 has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
200 participants
Enrollment target

Study Summary

Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since their first exposure to HIV treatment, the investigators will conduct a cross-sectional study with prospectively collected data to determine BMD in 200 subjects. Subjects identified were initially treatment naïve when entering the University of Alabama at Birmingham (UAB) 1917 HIV Clinic between 1999 and 2010; some have been under observation without being treated with ART therapy and others were newly started on ART therapy while under observation. For each subject, the investigators will determine associations between BMD and 1) cumulative viremia, 2) ART duration, and 3) ART type. Hypothesis 1a: BMD will be lowest in HIV+ subjects with the highest levels of cumulative viremia. Hypothesis 1b: BMD will be greatest in HIV+ persons with longest duration of ART therapy, after excluding those subjects treated with tenofovir. Hypotheses 1c: BMD will be lower in subjects treated with tenofovir vs. other ART agents, after controlling for duration of therapy. Additionally, the investigators will conduct a retrospective study in 100 patients HIV+ and were ART-naïve at the time of entry into the 1917 Clinic in whom the investigators will longitudinally evaluate the relationship between HIV viral load, inflammation, and bone turnover (through the measurement of HIV copy-years viremia, interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}, osteocalcin, and urine C-telopeptide {CTX}). The investigators will compare HIV patients at a similar stage of their disease who remain treatment naïve (either due to concerns for compliance or sufficient CD4 counts without treatment) (ART-) vs. those newly started on ART (ART+). Hypothesis 2: Viral load, markers of inflammation, and markers of bone resorption will all decrease in ART+ vs. ART- persons.

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2011-06
Est. Completion 2014-06
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01378494 record still lists

NCT01378494 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.

NCT01378494 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01378494 about?

NCT01378494 is a clinical study titled "Bone Mineral Density in HIV+ Patients". Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since their first exposure to HIV treatment, the investigators will conduct a cross-sectional study with prospectively collected data to determine BMD in 200 subjects. Subjects identified were initially treatment ...

What is the current status of trial NCT01378494?

This trial is currently completed. The enrollment target is 200 participants. The study started on 2011-06. Estimated completion is 2014-06.

Who is sponsoring clinical trial NCT01378494?

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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Source: ClinicalTrials.gov NCT01378494, the US trial registry maintained by the National Library of Medicine. NCT01378494 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.