BHVD: Bone Health and Vitamin D Status

Sponsor

Thai Red Cross AIDS Research Centre (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01634607

Collaborator

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

235

Enrollment

Location

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia Vitamin D Deficiency HIV Infection

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 Design

Study Type:

Observational

Anticipated Enrollment :

235 participants

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)

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

osteopenia [60 months]
development of osteopenia
vitamin D deficiency [60 months]
development of vitamin D deficiency
BMD [1 year]
changes of BMD

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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