Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART
Condition: HIV Infection
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of
      adolescents and young adults with HIV infection in the Adolescent Medicine Trials Network for
      HIV/AIDS Interventions (ATN) who are currently being treated with cART that includes
      tenofovir disoproxil fumarate (TDF) as one component of the regimen that includes at least
      three Food and Drug Administration (FDA)-approved antiretroviral (ARV) drugs for at least 180
      days.
    

Detailed description: 
      This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of
      adolescents and young adults with HIV infection in the ATN who are currently being treated
      with cART that includes TDF as one component of the regimen that includes at least three Food
      and Drug Administration (FDA)-approved ARVs for at least 180 days. Subjects must have at
      least one documented viral load that is below 200 copies/mL that is collected following
      initiation of TDF containing cART and greater than 90 days prior to randomization; no viral
      load above 200 copies/mL if measured within the 90 days prior to randomization; and an HIV
      viral load obtained at screening that is below 200 copies/mL.

      Treatment assignments will be balanced by subject sex at birth, age (<20 years vs. >=20
      years), and race (African American vs. other). Enrolled subjects will be randomized to
      receive vitamin D3 50000 IU or matching placebo, given orally every four weeks by DOT. In
      addition to the randomized study agent, all subjects will receive a MVI to be taken orally
      once daily. This "standard" MVI will contain ingredients not to exceed 600 IU of vitamin D3
      and 200 mg Ca.

      Dual energy x-ray absorptiometry (DXA) measurement of bone mineral content (BMC)/bone mineral
      density (BMD) of whole body, spine, and hip, will be performed at baseline and study weeks 24
      and 48. Blood and urine sampling to assess the Ca-phosphorous (PO4) axis, parathyroid hormone
      (PTH)-FGF23-vitamin D signaling, bone turnover, and renal glomerular and tubular function
      will occur at baseline and study weeks 12, 24, and 48. Blood samples to measure Gluc
      homeostasis will be drawn at baseline and week 48, and will be run by batch analysis.

      Safety, measured by serum calcium (SCa) and serum creatinine (SCr), will be monitored by
      subject's record review at study sites since these labs will generally be measured as a part
      of routine clinical care. The Adolescent Medicine Trials Network for HIV/AIDS Interventions
      109 (ATN 109) study will use the SCa and SCr values obtained within 10 weeks at the time of
      the visit beginning at the baseline visit. If these evaluations were not performed within the
      prior 10 weeks they will be drawn at the time of each visit. Viral load and cluster of
      differentiation 4 (CD4) cell count results will be recorded for this study, ATN 109, at
      screening, baseline and study weeks 12, 24, 48, and Post-Week 48 provided the evaluations
      were done within the protocol specified timeframe. If the evaluations were not performed
      within the protocol specified timeframes they will be drawn at the time of the visit.
    

Intervention name(s): Vitamin D3 50,000 IU; Vitamin D3 placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Group A: Vitamin D3 50,000 IU orally every four weeks by DOT; Group B: Vitamin D3 placebo orally every four weeks by DOT
Other intervention name(s): Vitamin D3; Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic