Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz

Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial

The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.

Study Overview

• Status: Unknown
• Conditions: Bone Density
• Intervention / Treatment: Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement; Other: TDF/3TC or FTC/EFV

Detailed Description

Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.

Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.

Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patawee Boontanondha, M.D.; Phone Number: 669-1774-6012; Email: pataweeb44@gmail.com
• Study Contact Backup: Name: Sasisopin Kiertiburanakul, M.D.MHS; Phone Number: 662-201-0033

Study Locations

• Thailand
  • Bangkok
    • Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400
      • Recruiting
      • Patawee Boontanondha
      • Contact: Patawee Boontanondha, M.D.; Phone Number: 669-1774-6012; Email: pataweeb44@gmail.com
      • Contact: Sasisopin Sasisopin Kiertiburanakul, MD, MHS; Phone Number: 662-201-0033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
• Age 18-50 years

Exclusion Criteria:

• CrCl <60mL/min/1.73 m2 ¶-
• CaCO3 supplement >500 mg/day or vitamin D supplement >800 IU/day
• Steroid used (equivalent to prednisolone> 5 mg/day more than 3 months )
• Osteoporosis treatment
• Serum Ca >10.5 g/dL
• History fragility fracture
• Pregnancy or breastfeeding
• Secondary amenorrhea
• Hyperthyroidism
• History of kidney stone
• Current active opportunistic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement; Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study	Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement; Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study; Other Names: ergocalciferol
OTHER: TDF/3TC or FTC/EFV; the subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.	Other: TDF/3TC or FTC/EFV; arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage change of bone density	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
change in 25(OH)D level	24 weeks

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Lamivudine; Ergocalciferols
• Other Study ID Numbers: ID 01-59-11 ว

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES