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
: January 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Infection | Drug: EFV/FTC/TDF Drug: Calcium Carbonate Drug: Vitamin D3 Drug: Placebo for calcium carbonate Drug: Placebo for vitamin D3 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 167 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART) |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
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Experimental: Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU.
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Drug: EFV/FTC/TDF
FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.
Other Name: Atripla
Drug: Calcium Carbonate
Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Drug: Vitamin D3
One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
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Experimental: Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo
Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.
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Drug: EFV/FTC/TDF
FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.
Other Name: Atripla
Drug: Placebo for calcium carbonate
A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Drug: Placebo for vitamin D3
A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
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- The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip [ Time Frame: Weeks 0 and 48 ]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)
- The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine [ Time Frame: Weeks 0 and 48 ]The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan
- Number of Participants With Primary Adverse Events [ Time Frame: From first study treatment to week 48 ]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
- The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48 [ Time Frame: Weeks 0, 24, and 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
- The Changes From Baseline in IL-6 to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in sCD14 to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in P1NP to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in CTX to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in HOMA-IR to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in Fasting LDL to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).
- The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 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%
- The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48 [ Time Frame: Weeks 0, 4, 12, 24 and 48 ]Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].
- The Changes From Baseline in iPTH to Weeks 24 and 48 [ Time Frame: Weeks 0, 24 and 48 ]iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infection
- No evidence of any exclusionary resistance mutations based on results from any genotype assay from any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent. Results must be available from testing any time in the past or must be obtained prior to entry and reviewed by the site investigator.
- ARV drug-naïve (<=10 days of ART at any time prior to entry) and no ARV drugs taken within the past 30 days.
- CD4+ cell count of any value obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
- HIV-1 RNA >1000 copies/mL obtained within 90 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.
- Certain laboratory values obtained within 30 days prior to entry (as indicated in section 4.1.6 of the protocol.
- Serum calcium < 10.5 mg/dL within 30 days prior to entry.
- For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
- Subjects must refrain from participating in a conception process (i.e., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two of the reliable forms of contraceptive listed in section 4.1.9 of the protocol.
- 25-OH vitamin D >=10 ng/mL and <75 ng/mL.
- Ability and willingness of subject or legally authorized representative to provide informed consent.
Exclusion Criteria:
- Current or prior use of bisphosphonate therapy.
- Use of vitamin D supplements greater than 800 IU/day within 30 days prior to entry.
- Use of calcium supplements greater than 500 mg/day within 30 days prior to entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
- Any oral, intravenous, or inhaled steroids within the 30 days prior to enrollment(intranasal steroid use is allowed).
- Use of androgenic hormones or growth hormones.
- Receipt of systemic cytotoxic chemotherapy within 30 days prior to entry.
- Pregnancy or currently breastfeeding.
- Documentation of acute opportunistic infections within 30 days prior to entry.
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to entry.
- Weight >300 lbs (exceeds weight limit of DXA scanners).
- History of nephrolithiasis (kidney stones).
- History of osteoporosis (as documented by DXA scan) or fragility fracture.
- Clinically active thyroid disease (use of thyroid hormone replacement therapy permitted but TSH must be in normal range).
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric illness.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403051

Study Chair: | Edgar (Turner) Overton, MD | Alabama Therapeutics CRS | |
Study Chair: | Michael T Yin, MD, MS | HIV Prevention & Treatment CRS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AIDS Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT01403051 History of Changes |
Other Study ID Numbers: |
ACTG A5280 1U01AI068636 ( U.S. NIH Grant/Contract ) |
First Posted: | July 27, 2011 Key Record Dates |
Results First Posted: | March 19, 2014 |
Last Update Posted: | January 28, 2016 |
Last Verified: | December 2015 |
Additional relevant MeSH terms:
Vitamins Vitamin D Ergocalciferols Cholecalciferol Calcium, Dietary Tenofovir Emtricitabine Efavirenz Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Calcium Carbonate Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antacids |