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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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Includes only subjects who did not have eligibility violations
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 86 participants | 165 participants | |
<=18 years |
0 0.0%
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0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
76 96.2%
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85 98.8%
|
161 97.6%
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>=65 years |
3 3.8%
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1 1.2%
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4 2.4%
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 79 participants | 86 participants | 165 participants | |
36
(28 to 47)
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31
(25 to 44)
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33
(26 to 46)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 86 participants | 165 participants | |
Female |
7 8.9%
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9 10.5%
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16 9.7%
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|
Male |
72 91.1%
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77 89.5%
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149 90.3%
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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 |
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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 |
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Number Analyzed | 79 participants | 86 participants | 165 participants | |
4.5
(4.1 to 5.1)
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4.5
(4.0 to 5.1)
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4.5
(4.1 to 5.1)
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[1]
Measure Description: Entry HIV-RNA level (log10 copies/mL)
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CD4 count
[1] Median (Inter-Quartile Range) Unit of measure: Cells/mm3 |
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Number Analyzed | 79 participants | 86 participants | 165 participants | |
339
(230 to 500)
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342
(232 to 454)
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341
(230 to 490)
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[1]
Measure Description: Entry total CD4 count (cells/mm3)
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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 |
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 |