Bone Health and Vitamin D Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-02-16

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.

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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.

Conditions

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Osteopenia Vitamin D Deficiency HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV uninfected

HIV negative patients

No interventions assigned to this group

HIV-infected, HAART naïve, high CD4 count

HIV positive patients with high CD4 and not on HIV treatment

No interventions assigned to this group

HIV-infected with planned to start HAART group

HIV positive patients who will start HIV treatment

No interventions assigned to this group

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes