Trial Outcomes & Findings for High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART (NCT NCT01403051)
NCT ID: NCT01403051
Last Updated: 2018-10-12
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Weeks 0 and 48
Results posted on
2018-10-12
Participant Flow
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.
Subjects were randomized with a 1:1 ratio at enrollment.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
86
|
|
Overall Study
Initiated Study Treatment
|
81
|
86
|
|
Overall Study
COMPLETED
|
71
|
80
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
Baseline characteristics by cohort
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=79 Participants
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
n=86 Participants
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
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
36 years
n=5 Participants
|
31 years
n=7 Participants
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
24 participants
n=5 Participants
|
30 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
23 participants
n=5 Participants
|
18 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian, Alaskan Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
86 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
HIV-1 RNA level
|
4.5 log10 copies/mL
n=5 Participants
|
4.5 log10 copies/mL
n=7 Participants
|
4.5 log10 copies/mL
n=5 Participants
|
|
CD4 count
|
339 cells/mm3
n=5 Participants
|
342 cells/mm3
n=7 Participants
|
341 cells/mm3
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 0 and 48Population: 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.
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)
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=65 Participants
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
n=77 Participants
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.
|
|---|---|---|
|
The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip
|
-1.46 percentage change
Interval -3.16 to -0.4
|
-3.19 percentage change
Interval -5.12 to -1.02
|
SECONDARY outcome
Timeframe: Weeks 0 and 48Population: 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.
The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=67 Participants
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
n=78 Participants
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.
|
|---|---|---|
|
The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine
|
-1.41 percentage change
Interval -3.78 to 0.0
|
-2.91 percentage change
Interval -4.84 to -1.06
|
SECONDARY outcome
Timeframe: From first study treatment to week 48Population: All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.
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
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=81 Participants
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
n=86 Participants
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.
|
|---|---|---|
|
Number of Participants With Primary Adverse Events
|
50 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Weeks 0, 24, and 48Population: 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.
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
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=71 Participants
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
n=74 Participants
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.
|
|---|---|---|
|
The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48
change from baseline to week 24
|
27.5 ng/mL
Interval 15.0 to 38.0
|
-0.8 ng/mL
Interval -5.9 to 4.9
|
|
The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48
change from baseline to week 48
|
24.2 ng/mL
Interval 14.3 to 35.8
|
0.6 ng/mL
Interval -6.1 to 4.3
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=66 Participants
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
n=68 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in IL-6 to Weeks 24 and 48
change from baseline to week 24
|
-0.05 log10 pg/mL
Interval -0.23 to 0.11
|
-0.04 log10 pg/mL
Interval -0.23 to 0.14
|
|
The Changes From Baseline in IL-6 to Weeks 24 and 48
change from baseline to week 48
|
-0.07 log10 pg/mL
Interval -0.24 to 0.12
|
-0.03 log10 pg/mL
Interval -0.23 to 0.1
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=68 Participants
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
n=68 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in sCD14 to Weeks 24 and 48
change from baseline to week 24
|
0.02 log10 ng/mL
Interval -0.08 to 0.15
|
0.00 log10 ng/mL
Interval -0.07 to 0.14
|
|
The Changes From Baseline in sCD14 to Weeks 24 and 48
change from baseline to week 48
|
0.07 log10 ng/mL
Interval -0.05 to 0.16
|
0.02 log10 ng/mL
Interval -0.06 to 0.14
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=72 Participants
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
n=77 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in P1NP to Weeks 24 and 48
change from baseline to week 24
|
11 ng/mL
Interval 2.0 to 26.0
|
21 ng/mL
Interval 12.0 to 38.0
|
|
The Changes From Baseline in P1NP to Weeks 24 and 48
change from baseline to week 48
|
15 ng/mL
Interval 0.0 to 29.0
|
18 ng/mL
Interval 7.0 to 39.0
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=72 Participants
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
n=77 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in CTX to Weeks 24 and 48
change from baseline to week 48
|
0.10 ng/mL
Interval -0.04 to 0.25
|
0.14 ng/mL
Interval 0.05 to 0.32
|
|
The Changes From Baseline in CTX to Weeks 24 and 48
change from baseline to week 24
|
0.11 ng/mL
Interval -0.01 to 0.27
|
0.22 ng/mL
Interval 0.11 to 0.35
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=69 Participants
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
n=73 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in HOMA-IR to Weeks 24 and 48
change from baseline to week 24
|
0.17 HOMA-IR
Interval -0.21 to 0.91
|
0.39 HOMA-IR
Interval -0.11 to 1.15
|
|
The Changes From Baseline in HOMA-IR to Weeks 24 and 48
change from baseline to week 48
|
0.13 HOMA-IR
Interval -0.26 to 1.11
|
0.26 HOMA-IR
Interval -0.44 to 0.79
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
Fasting total cholesterol changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=74 Participants
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
n=80 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48
change from baseline to week 24
|
11 mg/dL
Interval -4.0 to 29.0
|
18 mg/dL
Interval 1.0 to 31.0
|
|
The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48
change from baseline to week 48
|
13 mg/dL
Interval -6.0 to 28.0
|
14 mg/dL
Interval -1.0 to 37.0
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=70 Participants
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
n=72 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in Fasting LDL to Weeks 24 and 48
change from baseline to week 24
|
0 mg/dL
Interval -10.0 to 17.0
|
8 mg/dL
Interval -11.0 to 20.0
|
|
The Changes From Baseline in Fasting LDL to Weeks 24 and 48
change from baseline to week 48
|
2 mg/dL
Interval -9.0 to 14.0
|
4 mg/dL
Interval -14.0 to 27.0
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
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%
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=58 Participants
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
n=70 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48
change from baseline to week 24
|
0.7 percent
Interval -2.4 to 3.1
|
0.2 percent
Interval -1.8 to 3.8
|
|
The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48
change from baseline to week 48
|
0 percent
Interval -1.8 to 3.7
|
0.9 percent
Interval -1.9 to 4.0
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 12, 24 and 48Population: 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.
Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 \[week 4/12/24/48 - baseline\].
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=78 Participants
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
n=86 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
change from baseline to week 4
|
74 cells/mm^3
Interval 2.0 to 146.0
|
60 cells/mm^3
Interval 15.0 to 102.0
|
|
The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
change from baseline to week 12
|
103 cells/mm^3
Interval 41.0 to 170.0
|
106 cells/mm^3
Interval 60.0 to 216.0
|
|
The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
change from baseline to week 24
|
138 cells/mm^3
Interval 46.0 to 195.0
|
136 cells/mm^3
Interval 66.0 to 219.0
|
|
The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
change from baseline to week 48
|
192 cells/mm^3
Interval 113.0 to 305.0
|
201 cells/mm^3
Interval 108.0 to 292.0
|
SECONDARY outcome
Timeframe: Weeks 0, 24 and 48Population: 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.
iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( \[week 24-baseline\] and \[week 48 - baseline\], respectively).
Outcome measures
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=72 Participants
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
n=77 Participants
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.
|
|---|---|---|
|
The Changes From Baseline in iPTH to Weeks 24 and 48
change from baseline to week 24
|
0.4 pg/mL
Interval -3.8 to 5.7
|
4.2 pg/mL
Interval -0.8 to 9.3
|
|
The Changes From Baseline in iPTH to Weeks 24 and 48
change from baseline to week 48
|
1.1 pg/mL
Interval -4.0 to 6.1
|
5.2 pg/mL
Interval -0.7 to 12.6
|
Adverse Events
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF
Serious events: 7 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=81 participants at risk
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
n=86 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
General disorders
Pyrexia
|
2.5%
2/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Lyme disease
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Meningitis aseptic
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Infections and infestations
Wound infection
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Nervous system disorders
Convulsion
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Psychiatric disorders
Depression
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Psychiatric disorders
Depression suicidal
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
0.00%
0/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
1.2%
1/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
Other adverse events
| Measure |
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF
n=81 participants at risk
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
n=86 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.2%
5/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
3.5%
3/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Alanine aminotransferase abnormal
|
6.2%
5/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
2.3%
2/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
3/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
10.5%
9/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Aspartate aminotransferase abnormal
|
6.2%
5/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
3.5%
3/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
3/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
10.5%
9/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood albumin decreased
|
6.2%
5/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
7.0%
6/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood calcium decreased
|
4.9%
4/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
5.8%
5/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood cholesterol increased
|
29.6%
24/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
30.2%
26/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood glucose decreased
|
11.1%
9/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
22.1%
19/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood glucose increased
|
18.5%
15/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
18.6%
16/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood phosphorus decreased
|
27.2%
22/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
26.7%
23/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Blood sodium decreased
|
4.9%
4/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
9.3%
8/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Low density lipoprotein increased
|
18.5%
15/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
25.6%
22/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
|
Investigations
Neutrophil count decreased
|
3.7%
3/81 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
9.3%
8/86 • From first study treatment to week 48
Adverse events from patients' first study treatment date to off study date. medDRA version 16.1
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place