Bone Health and Vitamin D Status (BHVD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Thai Red Cross AIDS Research Centre
Sponsor:
Collaborators:
ViiV Healthcare
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT01634607
First received: July 2, 2012
Last updated: July 5, 2012
Last verified: July 2012

July 2, 2012
July 5, 2012
October 2010
October 2016   (final data collection date for primary outcome measure)
  • osteopenia [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of osteopenia
  • vitamin D deficiency [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    development of vitamin D deficiency
  • BMD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    changes of BMD
Same as current
Complete list of historical versions of study NCT01634607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bone Health and Vitamin D Status
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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).

  • Osteopenia
  • Vitamin D Deficiency
  • HIV Infection
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
235
October 2016
October 2016   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Yes
Contact: Reshmie Ramautarsing +662-255-7335 reshmie.r@hivnat.org
Contact: Nittaya Phanuphak +662-253-0996 nittaya.p@trcarc.org
Thailand
 
NCT01634607
TNT-HIV 003.1
No
Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre
  • ViiV Healthcare
  • HIV Netherlands Australia Thailand Research Collaboration
  • Bamrasnaradura Infectious Diseases Institute
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Praphan Phanuphak, MD The Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP