Bone Health and Vitamin D Status (BHVD)

February 15, 2023 updated by: Thai Red Cross AIDS Research Centre

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)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • The Thai Red Cross AIDS Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All participants are from the Anonymous Clinic of the Thai Red Cross AIDS Research Centre (TRC-ARC, the HIV Netherlands Australia Thailand Research Collaboration (HIVNAT) and Queen Savang Vadhana Memorial Hospital (QSV).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV uninfected
HIV negative patients
HIV-infected, HAART naïve, high CD4 count
HIV positive patients with high CD4 and not on HIV treatment
HIV-infected with planned to start HAART group
HIV positive patients who will start HIV treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thai Red Cross AIDS Research Centre

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ViiV Healthcare
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNT-HIV 003.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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