Preventing Bone Loss Among Chinese Patients With HIV on ART

NCT03598556 | Unknown DMC

• 1 other identifier: CACT 1807
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

HIV/AIDS; Osteoporosis; Bone Loss

Keywords

China; Anti-retroviral Therapy; Vitamin D; Tenofovir; Efavirenz; Lamivudine

Outcome Measures

Primary Outcomes (1)

• Change in Bone Mineral Density (BMD)

  In the three sites in Beijing (N=400), compare percent change in BMD at the lumbar spine and total hip, as measured by dual-energy x-ray absorptiometry (DXA) at week 48.

  Baseline to week 48

Secondary Outcomes (3)

• Immediate vs. Delayed Vitamin D3 Supplementation

  Weeks 48 to 96

• Change in Quantitative Ultrasound (QUS) Measures

  Baseline to 96 weeks

• Change in Biochemical Markers

  Baseline to 96 weeks

Study Arms (2)

Vitamin D3 Supplementation Arm

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

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.

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

180,000IU Vitamin D3 oral emulsion

Vitamin D3 Supplementation Arm

Placebo OTHER

Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing YouAn Hospital: collaborator
• Beijing Ditan Hospital: collaborator
• Guangxi Autonomous Region Longtan Hospital: collaborator
• Fuzhou Infectious Diseases Hospital: collaborator
• Shenzhen Third People's Hospital: collaborator
• Yale University: collaborator

Study Sites (6)

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Location

Beijing Youan Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Fuzhou Infectious Diseases Hospital

Fuzhou, Fujian, China

Location

Shenzhen Third Hospital

Shenzhen, Guangdong, China

Location

Longtan Hospital

Liuchow, Guangxi Autonomous Region, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Osteoporosis; Bone Diseases, Metabolic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Taisheng Li, MD, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Infectious Diseases

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (6)