Bone Health and Vitamin D Status (BHVD)

Thai Red Cross AIDS Research Centre

Status: Completed

Conditions: Osteopenia; Vitamin D Deficiency; HIV Infection

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT01634607

TNT-HIV 003.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

235 participants in 3 patient groups

HIV uninfected

Description:

HIV negative patients

HIV-infected, HAART naïve, high CD4 count

Description:

HIV positive patients with high CD4 and not on HIV treatment

HIV-infected with planned to start HAART group

Description:

HIV positive patients who will start HIV treatment