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Clinical trialNCT01378494CompletedObservational

Bone Mineral Density in HIV+ Patients

SponsorUniversity of Alabama at BirminghamEnrollment200Osteoporosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Uab

    Birmingham, Alabama, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2011
Primary completion
30 Jun 2014
Completion
30 Jun 2014
Last update posted
2 Jun 2016
Registered enrollment
200
Registry id
NCT01378494

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.