High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
NCT ID: NCT01403051
Last Updated: 2018-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2011-09-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Calcium Carbonate
Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Vitamin D3
One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
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.
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.
Placebo for calcium carbonate
A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
Placebo for vitamin D3
A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Interventions
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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.
Calcium Carbonate
Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
Vitamin D3
One Vitamin D3 4000 IU capsule taken orally once daily 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
Placebo for vitamin D3
A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Edgar (Turner) Overton, MD
Role: STUDY_CHAIR
Alabama Therapeutics CRS
Michael T Yin, MD, MS
Role: STUDY_CHAIR
HIV Prevention & Treatment CRS
Locations
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Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States
Usc Crs (1201)
Los Angeles, California, United States
UCLA CARE Center CRS (601)
Los Angeles, California, United States
Stanford CRS (501)
Palo Alto, California, United States
Ucsd, Avrc Crs (701)
San Diego, California, United States
Ucsf Aids Crs (801)
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
Georgetown University CRS (GU CRS) (1008)
Washington D.C., District of Columbia, United States
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
Rush University Medical Center (2702)
Chicago, Illinois, United States
IHV Baltimore Treatment CRS (4651)
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS (103)
Boston, Massachusetts, United States
Washington University CRS (2101)
St Louis, Missouri, United States
New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)
Newark, New Jersey, United States
Cornell CRS (7804)
New York, New York, United States
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States
HIV Prevention & Treatment CRS (30329)
New York, New York, United States
AIDS Care CRS (1108)
Rochester, New York, United States
University of Rochester ACTG CRS (1101)
Rochester, New York, United States
Bronx-Lebanon Hosp. Ctr. CRS (31469)
The Bronx, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
Duke University Medical Center Adult CRS (1601)
Durham, North Carolina, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS (3203)
Greensboro, North Carolina, United States
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, United States
Case CRS (2501)
Cleveland, Ohio, United States
MetroHealth CRS (2503)
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS (2301)
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, United States
Pittsburgh CRS (1001)
Pittsburgh, Pennsylvania, United States
The Miriam Hosp. ACTG CRS (2951)
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS (3652)
Nashville, Tennessee, United States
Trinity Health and Wellness Center CRS (31443)
Dallas, Texas, United States
Houston AIDS Research Team CRS (31473)
Houston, Texas, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, United States
Puerto Rico-AIDS CRS (5401)
San Juan, , Puerto Rico
Countries
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References
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Yin MT, Chan ES, Brown TT, Kinslow J, Martinson J, Landay A, Melbourne KM, Ribaudo HJ, Overton ET; A5280 Study Team. Vitamin D does not modulate immune-mediated bone loss during ART initiation. Antivir Ther. 2019;24(5):355-362. doi: 10.3851/IMP3316.
Yin MT, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Overton ET; A5280 Study Team. Racial differences in calculated bioavailable vitamin D with vitamin D/calcium supplementation. AIDS. 2017 Nov 13;31(17):2337-2344. doi: 10.1097/QAD.0000000000001621.
Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Yin MT. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):815-24. doi: 10.7326/M14-1409.
Other Identifiers
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ACTG A5280
Identifier Type: -
Identifier Source: org_study_id
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