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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:September 2011
End Date:February 2013

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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)

This study was done with people who were infected with HIV and needed to start treatment for
their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will
help prevent the bone loss that sometimes happens when people start HIV treatment. For this
study, the following HIV treatment (or HAART) were provided in the form of a single tablet
that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These
drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common
for people who are taking HIV drugs for the first time. The risks seen with this HIV
treatment are the same that you would encounter when taking these drugs outside of the study.
The lists of risks of this HIV treatment are included in this document because the drugs are
provided by the study, not because the drugs are being tested. The purpose of the study is
only to look at the impact of high doses of vitamin D and calcium in preventing bone loss.
There are no study objectives related to HIV treatment (EFV/FTC/TDF).


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.
We found this trial at
39
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Atlanta, Georgia 30308
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Baltimore, Maryland 21201
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Birmingham, Alabama 35294
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Boston, Massachusetts 02115
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Boston, Massachusetts 02114
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Bronx, New York 10457
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Chapel Hill, North Carolina 27514
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Chicago, Illinois 60611
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Chicago, Illinois 60612
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44106
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Cleveland, Ohio 44109
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Durham, North Carolina 27710
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Los Angeles, California 90095
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Los Angeles, California 90033
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Nashville, Tennessee 37204
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New York, New York 10032
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New York, New York 10016
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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Providence, Rhode Island 02906
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Saint Louis, Missouri 63110
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San Diego, California 92103
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San Francisco, California 94110
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San Juan, 00935
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Torrance, California 90502
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Washington, District of Columbia 20007
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