Bone Mineral Density in HIV+ Patients

NCT01378494 | Completed

• 1 other identifier: F110105006
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis

Keywords

osteoporosis; bone; HIV; antiretrovirals; inflammation

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Baseline

Secondary Outcomes (1)

• Pro-inflammatory and bone turnover markers

  6-12 months apart

Study Arms (1)

HIV+

HIV+ patients that entered the 1917 Clinic at UAB as naive to ART

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ART-naïve patients or patients followed since their first exposure to HIV treatment at the 1917 Clinic

You may qualify if:

• All treatment naïve patients seen in the 1917 Clinic between January 1, 1999 and December 31, 2010 will be identified.
• Of these patients, those who are currently under care at the time of the initiation of the study (\>1 clinic visit in the past 12 months) will be eligible (regardless of current use of ART treatment).

You may not qualify if:

• Patients with a history of chronic renal failure (estimated GFR \<30ml/min) will be excluded from the study.
• In addition, patients with a known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta), multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen) will be excluded from participation.
• Patients treated with oral glucocorticoids and anticonvulsants will also be excluded.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35242, United States

Location

MeSH Terms

Conditions

Osteoporosis; Inflammation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy H Warriner, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 2, 2016

Record last verified: 2016-05

Locations

US (1)