Bone Health and Vitamin D Status

Study Overview
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Brief Summary
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This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.

Detailed Description
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To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.

Official Title
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Bone Health and Vitamin D Status in Thai HIV-1 Infected and Uninfected Adults (A Substudy of TNT-HIV 003: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study)

Conditions
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Osteopenia, Vitamin D Deficiency, HIV Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV uninfected: HIV negative confirmed by HIV testing Age 30 years and older Thai nationality Signed informed consent form for the study HIV-infected, HAART naïve: Recorded HIV infection Age 30 years and older Thai nationality Signed informed consent form for the study HIV-infected, HAART group: Recorded HIV infection Age 30 years and older Thai nationality HAART naïve at baseline, planned to start HAART within 90 days. Past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of HIV ≥ 3 months prior to screening will be allowed Signed informed consent form for the study Exclusion Criteria: HIV uninfected Currently pregnant or lactating Recent hospitalization Use of anticonvulsants, steroids or vitamin D supplements HIV-infected, HAART naïve CD4 < 350 Currently pregnant/lactating Recent hospitalization Signs of wasting Use of anticonvulsants, steroids or vitamin D supplements HIV-infected, HAART group: Prior antiretroviral therapy use Currently pregnant/lactating Recent hospitalization Signs of wasting Active opportunistic infection Use of anticonvulsants, steroids or vitamin D supplements

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV uninfected<br>HIV negative patients | |
| HIV-infected, HAART naïve, high CD4 count<br>HIV positive patients with high CD4 and not on HIV treatment | |
| HIV-infected with planned to start HAART group<br>HIV positive patients who will start HIV treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| osteopenia | development of osteopenia | 60 months | 
| vitamin D deficiency | development of vitamin D deficiency | 60 months | 
| BMD | changes of BMD | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopenia, vitamin D deficiency, HIV-infected patients, bone health, Bone mineral density (BMD), HIV-uninfected patients, effects of TDF on the patients' bone