Trial | NCT03598556  Report issue

Title

Preventing Bone Loss Among Chinese Patients With HIV on ART
Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    600
The major goal of this study will be to conduct a randomized, double-blind, placebo-controlled, clinical trial of intermittent high-dose vitamin D3 supplementation (180,000IU) given at the point of care (every 3 months) after initiation of ART with tenofovir/ lamivudine/ efavirenz to compare its ability to mitigate reductions in bone mineral density over 12 months compared to placebo.
Studies among adult and pediatric populations have suggested vitamin D supplementation may be efficacious for mitigating the bone loss seen with tenofovir-based antiretroviral therapy (ART). Because patients with HIV face significant pill burden, competing priorities and health care associated costs, we seek to explore a pragmatic approach to prevention. The investigators propose a randomized controlled, double-blind, placebo intervention trial to assess the efficacy, tolerability, and safety of an intermittent high-dose vitamin D3 supplementation regimen given quarterly at the point of care for adult patients receiving free ART through the China National Free AIDS Treatment Program. The period of supplementation will be limited to the first 48 weeks after treatment initiation when ART-associated bone loss is most pronounced. This will be followed by supplementation of all participants with vitamin D3 from 48 to 96 weeks to compare the impact of early vitamin D3 supplementation (at ART initiation) versus late vitamin D3 supplementation (at 48 weeks) on change in BMD.

Furthermore, despite the rapid rise in access to ART in China, infrastructure to diagnose and manage osteoporosis is not always easily accessible for patients with HIV in China due to limited availability of dual-energy x-ray absorptiometry (DXA), the gold standard for BMD measurement. Therefore, the current proposal also seeks to bridge this gap by exploring the potential applications of quantitative ultrasound (QUS), a portable and low-cost method of assessing BMD that has been demonstrated to reliably predict fracture, in HIV care settings.

A total of 400 treatment-naïve Chinese adults diagnosed with HIV from 3 study sites in Beijing will be enrolled and followed with serial DXA exams to evaluate the primary aim. These 400 patients plus another 200 participants from 3 additional study sites from Fuzhou, Shenzhen, and Guangxi province, will be evaluated with serial QUS ultrasound examinations for the secondary aims. Serum and urine samples will be collected and stored at pre-specified time points.
Study Started
Jun 01
2018
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Jul 07
2020

Dietary Supplement Vitamin D3

180,000IU Vitamin D3 oral emulsion

Other Placebo

Placebo

Vitamin D3 Supplementation Arm Experimental

This arm will receive 180,000IU vitamin D3 every 3 months from baseline through week 96.

Placebo Arm Placebo Comparator

This arm will receive placebo every 3 months from baseline through week 48, followed by 180,000IU vitamin D3 every 3 months from week 48 through week 96.

Criteria 

Inclusion Criteria:

Provision of signed and dated informed consent form
Willingness and availability to engage in study activities for the duration of the study
Documented HIV-1 infection (confirmed by Western blot)
ART naïve at the time of enrollment
Eligible to initiate ART (TDF/3TC/EFV) within 1 month
Ability to take oral medication and be willing to adhere to the mediation regimen
For females of reproductive potential: use of highly effective contraception

Exclusion Criteria:

Pregnancy or breastfeeding
AIDS-defining illness within 2 weeks of entry
Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
Patients with a history of injection drug usage
Known history of osteoporosis, osteoporotic fracture, or other metabolic/inherited bone disorder
History of treatment with prescription therapies for osteoporosis (for example: bisphosphonates, denosumab, teriparatide, selective estrogen receptor modifying agents, active forms of vitamin D).
Unwillingness to discontinue previous vitamin D supplementation, if any, at time of enrollment
Rheumatoid arthritis
Malabsorption or inflammatory bowel disease
Hyperparathyroidism, hypercalcemia, or hypocalcemia
History of kidney stones
Poorly controlled thyroid disease
History of neuromuscular disorder/movement disorder, stroke or seizures
History of significant neurocognitive disorders (including mental health conditions or dementia)
Glucocorticoids, estrogen, testosterone, or anticonvulsant use within the past six months
No Results Posted