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

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.