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

Mahidol University

Status: Unknown

Conditions: Bone Density

Treatments: Other: TDF/3TC or FTC/EFV; Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02827643

ID 01-59-11 ว

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement

Active Comparator group

Description:

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

Treatment:

Drug: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement

TDF/3TC or FTC/EFV

Other group

Description:

the subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.

Treatment:

Other: TDF/3TC or FTC/EFV