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Completed

NCT Number: NCT01634607

Bone Health and Vitamin D Status

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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Key information

Conditions

Osteopenia Avitaminosis Blood-Borne Infections Bone Diseases Bone Diseases, Metabolic Communicable Diseases Deficiency Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases Vitamin D Deficiency

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. osteopenia

    Time frame: 60 months

    development of osteopenia

  2. vitamin D deficiency

    Time frame: 60 months

    development of vitamin D deficiency

  3. BMD

    Time frame: 1 year

    changes of BMD

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

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

Registry information

Official study title

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)

Acronym: BHVD

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jul 6, 2012
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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