NCT01634607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
7.4 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

February 17, 2023

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

July 2, 2012

Last Update Submit

February 15, 2023

Conditions

OsteopeniaVitamin D DeficiencyHIV Infection

Keywords

osteopeniavitamin D deficiencyHIV-infected patientsbone healthBone mineral density (BMD)HIV-uninfected patientseffects of TDF on the patients' bone

Outcome Measures

Primary Outcomes (3)

  • osteopenia

    development of osteopenia

    60 months

  • vitamin D deficiency

    development of vitamin D deficiency

    60 months

  • BMD

    changes of BMD

    1 year

Study Arms (3)

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

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 32210458DERIVED

MeSH Terms

Conditions

Bone Diseases, MetabolicVitamin D DeficiencyHIV Infections

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Praphan Phanuphak, MD

    The Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

December 1, 2019

Primary Completion

July 15, 2021

Study Completion

February 16, 2023

Last Updated

February 17, 2023

Record last verified: 2021-10

Locations

TH(1)