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Bone Health and Vitamin D Status (BHVD)

This study is currently recruiting participants.
Verified July 2012 by Thai Red Cross AIDS Research Centre
Sponsor:
Collaborators:
ViiV Healthcare
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
The Netherlands Centre for Poverty-related Communicable Diseases (CPCD), University of Amsterdam Academic Medical Centre (AMC)
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
History of Changes
  Purpose

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.


Condition
Osteopenia
Vitamin D Deficiency
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 235
Study Start Date: October 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634607

Contacts
Contact: Reshmie Ramautarsing +662-255-7335 reshmie.r@hivnat.org
Contact: Nittaya Phanuphak +662-253-0996 nittaya.p@trcarc.org

Locations
Thailand
The Thai Red Cross AIDS Research Centre Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Reshmie Ramautarsing     +662-255-7335     reshmie.r@hivnat.org    
Contact: Nittaya Phanuphak     +662-253-0996     nittaya.p@trcarc.org    
Principal Investigator: Praphan Phanuphak            
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
ViiV Healthcare
HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Infectious Diseases Institute
The Netherlands Centre for Poverty-related Communicable Diseases (CPCD), University of Amsterdam Academic Medical Centre (AMC)
Investigators
Principal Investigator: Praphan Phanuphak, MD The Thai Red Cross AIDS Research Centre
  More Information

No publications provided

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01634607     History of Changes
Other Study ID Numbers: TNT-HIV 003.1
Study First Received: July 2, 2012
Last Updated: July 5, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Thai Red Cross AIDS Research Centre:
osteopenia
vitamin D deficiency
HIV-infected patients
bone health
 Bone mineral density (BMD)
HIV-uninfected patients
effects of TDF on the patients' bone

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bone Diseases, Metabolic
Vitamin D Deficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bone Diseases
 Musculoskeletal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013