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

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ClinicalTrials.gov Identifier: NCT01403051
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : March 19, 2014
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
Enrollment 167
Recruitment Details 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 Subjects were randomized with a 1:1 ratio at enrollment.
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 81 86
Initiated Study Treatment 81 86
Completed 71 80
Not Completed 10 6
Reason Not Completed
Protocol Violation             2             0
Death             1             0
Withdrawal by Subject             2             1
Lost to Follow-up             5             5
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 79 86 165
Hide Baseline Analysis Population Description
Includes only subjects who did not have eligibility violations
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 86 participants 165 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
76
  96.2%
85
  98.8%
161
  97.6%
>=65 years
3
   3.8%
1
   1.2%
4
   2.4%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 79 participants 86 participants 165 participants
36
(28 to 47)
31
(25 to 44)
33
(26 to 46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 86 participants 165 participants
Female
7
   8.9%
9
  10.5%
16
   9.7%
Male
72
  91.1%
77
  89.5%
149
  90.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 86 participants 165 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 79 participants 86 participants 165 participants
79 86 165
HIV-1 RNA level   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 79 participants 86 participants 165 participants
4.5
(4.1 to 5.1)
4.5
(4.0 to 5.1)
4.5
(4.1 to 5.1)
[1]
Measure Description: Entry HIV-RNA level (log10 copies/mL)
CD4 count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm3
Number Analyzed 79 participants 86 participants 165 participants
339
(230 to 500)
342
(232 to 454)
341
(230 to 490)
[1]
Measure Description: Entry total CD4 count (cells/mm3)
1.Primary Outcome
Title The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip
Hide Description The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)
Time Frame Weeks 0 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 65 77
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-1.46
(-3.16 to -0.40)
-3.19
(-5.12 to -1.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF, Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Comments The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments 2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.
Method Stratified Wilcoxon rank sum test
Comments Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (<=20 vs. >20 ng/mL)
2.Secondary Outcome
Title The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine
Hide Description The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan
Time Frame Weeks 0 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 67 78
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-1.41
(-3.78 to 0.00)
-2.91
(-4.84 to -1.06)
3.Secondary Outcome
Title Number of Participants With Primary Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 81 86
Measure Type: Number
Unit of Measure: participants
50 53
4.Secondary Outcome
Title The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48
Hide Description

Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL

Time Frame Weeks 0, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 71 74
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
change from baseline to week 24
27.5
(15.0 to 38.0)
-0.8
(-5.9 to 4.9)
change from baseline to week 48
24.2
(14.3 to 35.8)
0.6
(-6.1 to 4.3)
5.Secondary Outcome
Title The Changes From Baseline in IL-6 to Weeks 24 and 48
Hide Description Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 66 68
Median (Inter-Quartile Range)
Unit of Measure: log10 pg/mL
change from baseline to week 24
-0.05
(-0.23 to 0.11)
-0.04
(-0.23 to 0.14)
change from baseline to week 48
-0.07
(-0.24 to 0.12)
-0.03
(-0.23 to 0.10)
6.Secondary Outcome
Title The Changes From Baseline in sCD14 to Weeks 24 and 48
Hide Description Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 68 68
Median (Inter-Quartile Range)
Unit of Measure: log10 ng/mL
change from baseline to week 24
0.02
(-0.08 to 0.15)
0.00
(-0.07 to 0.14)
change from baseline to week 48
0.07
(-0.05 to 0.16)
0.02
(-0.06 to 0.14)
7.Secondary Outcome
Title The Changes From Baseline in P1NP to Weeks 24 and 48
Hide Description P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 72 77
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
change from baseline to week 24
11
(2 to 26)
21
(12 to 38)
change from baseline to week 48
15
(0 to 29)
18
(7 to 39)
8.Secondary Outcome
Title The Changes From Baseline in CTX to Weeks 24 and 48
Hide Description CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 72 77
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
change from baseline to week 24
0.11
(-0.01 to 0.27)
0.22
(0.11 to 0.35)
change from baseline to week 48
0.10
(-0.04 to 0.25)
0.14
(0.05 to 0.32)
9.Secondary Outcome
Title The Changes From Baseline in HOMA-IR to Weeks 24 and 48
Hide Description Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 69 73
Median (Inter-Quartile Range)
Unit of Measure: HOMA-IR
change from baseline to week 24
0.17
(-0.21 to 0.91)
0.39
(-0.11 to 1.15)
change from baseline to week 48
0.13
(-0.26 to 1.11)
0.26
(-0.44 to 0.79)
10.Secondary Outcome
Title The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48
Hide Description Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 80
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
change from baseline to week 24
11
(-4 to 29)
18
(1 to 31)
change from baseline to week 48
13
(-6 to 28)
14
(-1 to 37)
11.Secondary Outcome
Title The Changes From Baseline in Fasting LDL to Weeks 24 and 48
Hide Description Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 70 72
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
change from baseline to week 24
0
(-10 to 17)
8
(-11 to 20)
change from baseline to week 48
2
(-9 to 14)
4
(-14 to 27)
12.Secondary Outcome
Title The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48
Hide Description

Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

Fractional Excretion of Phosphate (in %) is defined as:

[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%

Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 58 70
Median (Inter-Quartile Range)
Unit of Measure: percent
change from baseline to week 24
0.7
(-2.4 to 3.1)
0.2
(-1.8 to 3.8)
change from baseline to week 48
0
(-1.8 to 3.7)
0.9
(-1.9 to 4.0)
13.Secondary Outcome
Title The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
Hide Description Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].
Time Frame Weeks 0, 4, 12, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 78 86
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
change from baseline to week 4
74
(2 to 146)
60
(15 to 102)
change from baseline to week 12
103
(41 to 170)
106
(60 to 216)
change from baseline to week 24
138
(46 to 195)
136
(66 to 219)
change from baseline to week 48
192
(113 to 305)
201
(108 to 292)
14.Secondary Outcome
Title The Changes From Baseline in iPTH to Weeks 24 and 48
Hide Description iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
Time Frame Weeks 0, 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description

Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.

n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48.

Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 72 77
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
change from baseline to week 24
0.4
(-3.8 to 5.7)
4.2
(-0.8 to 9.3)
change from baseline to week 48
1.1
(-4.0 to 6.1)
5.2
(-0.7 to 12.6)
Time Frame From first study treatment to week 48
Adverse Event Reporting Description

Adverse events from patients' first study treatment date to off study date.

medDRA version 16.1

 
Arm/Group Title Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   8/81 (9.88%)   7/86 (8.14%) 
Gastrointestinal disorders     
Mallory-Weiss syndrome  1  1/81 (1.23%)  0/86 (0.00%) 
General disorders     
Pyrexia  1  2/81 (2.47%)  0/86 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/81 (1.23%)  0/86 (0.00%) 
Infections and infestations     
Gastroenteritis  1  0/81 (0.00%)  1/86 (1.16%) 
Gastroenteritis viral  1  0/81 (0.00%)  1/86 (1.16%) 
Herpes zoster  1  1/81 (1.23%)  0/86 (0.00%) 
Lyme disease  1  0/81 (0.00%)  1/86 (1.16%) 
Meningitis aseptic  1  1/81 (1.23%)  0/86 (0.00%) 
Pneumonia streptococcal  1  0/81 (0.00%)  1/86 (1.16%) 
Wound infection  1  0/81 (0.00%)  1/86 (1.16%) 
Injury, poisoning and procedural complications     
Laceration  1  1/81 (1.23%)  0/86 (0.00%) 
Investigations     
Aspartate aminotransferase increased  1  0/81 (0.00%)  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  1/81 (1.23%)  0/86 (0.00%) 
Uterine leiomyoma  1  1/81 (1.23%)  0/86 (0.00%) 
Nervous system disorders     
Convulsion  1  1/81 (1.23%)  0/86 (0.00%) 
Psychiatric disorders     
Depression  1  0/81 (0.00%)  1/86 (1.16%) 
Depression suicidal  1  1/81 (1.23%)  0/86 (0.00%) 
Suicide attempt  1  0/81 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders     
Renal failure  1  1/81 (1.23%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/81 (0.00%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders     
Drug reaction with eosinophilia and systemic symptoms  1  0/81 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Affected / at Risk (%) Affected / at Risk (%)
Total   60/81 (74.07%)   70/86 (81.40%) 
Gastrointestinal disorders     
Nausea  1  5/81 (6.17%)  3/86 (3.49%) 
Investigations     
Alanine aminotransferase abnormal  1  5/81 (6.17%)  2/86 (2.33%) 
Alanine aminotransferase increased  1  3/81 (3.70%)  9/86 (10.47%) 
Aspartate aminotransferase abnormal  1  5/81 (6.17%)  3/86 (3.49%) 
Aspartate aminotransferase increased  1  3/81 (3.70%)  9/86 (10.47%) 
Blood albumin decreased  1  5/81 (6.17%)  6/86 (6.98%) 
Blood calcium decreased  1  4/81 (4.94%)  5/86 (5.81%) 
Blood cholesterol increased  1  24/81 (29.63%)  26/86 (30.23%) 
Blood glucose decreased  1  9/81 (11.11%)  19/86 (22.09%) 
Blood glucose increased  1  15/81 (18.52%)  16/86 (18.60%) 
Blood phosphorus decreased  1  22/81 (27.16%)  23/86 (26.74%) 
Blood sodium decreased  1  4/81 (4.94%)  8/86 (9.30%) 
Low density lipoprotein increased  1  15/81 (18.52%)  22/86 (25.58%) 
Neutrophil count decreased  1  3/81 (3.70%)  8/86 (9.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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
Layout table for Results Point of Contact information
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01403051    
Other Study ID Numbers: ACTG A5280
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2011
First Posted: July 27, 2011
Results First Submitted: February 5, 2014
Results First Posted: March 19, 2014
Last Update Posted: October 12, 2018