High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01403051
First received: July 25, 2011
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: February 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: EFV/FTC/TDF
Drug: Calcium Carbonate
Drug: Vitamin D3
Drug: Placebo for calcium carbonate
Drug: Placebo for vitamin D3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A5280 opened under version 1.0 on September 15, 2011, and the first subject was randomized on September 26, 2011. Accrual to the study closed on March 2, 2012, with a total of 167 subjects enrolled from 39 sites within the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized with a 1:1 ratio at enrollment.

Reporting Groups
  Description
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF

The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).

Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF

The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)

Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.


Participant Flow:   Overall Study
    Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF     Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF  
STARTED     81     86  
Initiated Study Treatment     81     86  
COMPLETED     71     80  
NOT COMPLETED     10     6  
Protocol Violation                 2                 0  
Death                 1                 0  
Withdrawal by Subject                 2                 1  
Lost to Follow-up                 5                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes only subjects who did not have eligibility violations

Reporting Groups
  Description
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF

The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).

Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF

The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).

Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

Total Total of all reporting groups

Baseline Measures
    Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF     Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF     Total  
Number of Participants  
[units: participants]
  79     86     165  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     76     85     161  
>=65 years     3     1     4  
Age  
[units: years]
Median ( Inter-Quartile Range )
  36  
  ( 28 to 47 )  
  31  
  ( 25 to 44 )  
  33  
  ( 26 to 46 )  
Gender  
[units: participants]
     
Female     7     9     16  
Male     72     77     149  
Race/Ethnicity, Customized  
[units: participants]
     
White Non-Hispanic     28     33     61  
Black Non-Hispanic     24     30     54  
Hispanic (Regardless of Race)     23     18     41  
Asian, Pacific Islander     2     5     7  
American Indian, Alaskan Native     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     79     86     165  
HIV-1 RNA level [1]
[units: log10┬ácopies/mL]
Median ( Inter-Quartile Range )
  4.5  
  ( 4.1 to 5.1 )  
  4.5  
  ( 4.0 to 5.1 )  
  4.5  
  ( 4.1 to 5.1 )  
CD4 count [2]
[units: cells/mm3]
Median ( Inter-Quartile Range )
  339  
  ( 230 to 500 )  
  342  
  ( 232 to 454 )  
  341  
  ( 230 to 490 )  
[1] Entry HIV-RNA level (log10 copies/mL)
[2] Entry total CD4 count (cells/mm3)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip   [ Time Frame: Weeks 0 and 48 ]

2.  Secondary:   The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine   [ Time Frame: Weeks 0 and 48 ]

3.  Secondary:   Number of Participants With Primary Adverse Events   [ Time Frame: From first study treatment to week 48 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Number of Participants With Primary Adverse Events
Measure Description Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table
Time Frame From first study treatment to week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.

Reporting Groups
  Description
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF

The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).

Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF

The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)

Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.


Measured Values
    Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF     Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF  
Number of Participants Analyzed  
[units: participants]
  81     86  
Number of Participants With Primary Adverse Events  
[units: participants]
  50     53  

No statistical analysis provided for Number of Participants With Primary Adverse Events



4.  Secondary:   The Change From Baseline in 25-OH Vitamin D Level   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

5.  Secondary:   The Changes From Baseline in Markers of Bone Turnover   [ Time Frame: Weeks 0, 24 and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

6.  Secondary:   The Changes From Baseline in Markers of Inflammation   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

7.  Secondary:   The Changes From Baseline in Fasting Lipids   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

8.  Secondary:   The Change From Baseline in Urinary Phosphate Excretion   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

9.  Secondary:   The Change From Baseline in CD4+ Count   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No

10.  Secondary:   The Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels   [ Time Frame: Weeks 0, 24, and 48 ]
Results not yet posted.   Anticipated Posting Date:   06/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: 617-432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


No publications provided


Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01403051     History of Changes
Other Study ID Numbers: ACTG A5280, 1U01AI068636
Study First Received: July 25, 2011
Results First Received: February 5, 2014
Last Updated: March 18, 2014
Health Authority: United States: Federal Government