High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
Condition: HIV-1 Infection
Intervention: EFV/FTC/TDF; Calcium Carbonate; Vitamin D3; Placebo for calcium carbonate; Placebo for vitamin D3
Intervention description: 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 500 mg tablet taken orally twice daily with food for 48 weeks.; One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.; A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks; A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.