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NCT01634607 Clinical Trial

Bone Health and Vitamin D Status

Vitamin D Deficiency Clinical Trial

— BHVD  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01634607
Other study ID # TNT-HIV 003.1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date February 16, 2023

Study information
Verified date October 2021
Source Thai Red Cross AIDS Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date February 16, 2023
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand The Thai Red Cross AIDS Research Centre Pathum Wan Bangkok

Sponsors (5)
Lead Sponsor Collaborator
Thai Red Cross AIDS Research Centre Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bamrasnaradura Infectious Diseases Institute, HIV Netherlands Australia Thailand Research Collaboration, ViiV Healthcare

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary osteopenia development of osteopenia 60 months
Primary vitamin D deficiency development of vitamin D deficiency 60 months
Primary BMD changes of BMD 1 year
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