Clinical trial NCT01634607: Bone Health and Vitamin D Status
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenia
Vitamin D Deficiency
HIV Infection
Keywords: osteopenia
vitamin D deficiency
HIV-infected patients
bone health
Bone mineral density (BMD)
HIV-uninfected patients
effects of TDF on the patients' bone
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: HIV Netherlands Australia Thailand Research Collaboration
name: Bamrasnaradura Infectious Diseases Institute
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2012-07-06
Enrollment: 235
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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 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

Primary outcomes:
measure: osteopenia
timeFrame: 60 months
measure: vitamin D deficiency
timeFrame: 60 months
measure: BMD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
affiliation: The Thai Red Cross AIDS Research Centre
name: Praphan Phanuphak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han WM, Wattanachanya L, Apornpong T, Jantrapakde J, Avihingsanon A, Kerr SJ, Teeratakulpisarn N, Jadwattanakul T, Chaiwatanarat T, Buranasupkajorn P, Ramautarsing R, Phanuphak N, Sunthornyothin S, Ruxrungtham K, Phanuphak P; TNT 003.1 study team. Bone mineral density changes among people living with HIV who have started with TDF-containing regimen: A five-year prospective study. PLoS One. 2020 Mar 25;15(3):e0230368. doi: 10.1371/journal.pone.0230368. eCollection 2020.