A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 50,000 IU Every 4 Weeks to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in Youth With HIV Infection Being Treated With Tenofovir-Containing Combination Antiretroviral Therapy (cART)
Inclusion and Exclusion Criteria
- To be considered eligible for enrollment, an individual must meet the criteria listed below at the time of randomization: NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan.
- Age 16 years and 0 days to 24 years and 364 days;
- Behaviorally infected with HIV (e.g., sexual contact, injection drug use; not infected by perinatal transmission, blood transfusion, or at age younger than 9 years);
- HIV-1 infection as documented in subject's medical record by at least one of the following criteria:
- reactive HIV screening test result with an antibody based FDA-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 Indirect Immunofluorescence, Antibody Differentiation Assay (Multispot)); or
- positive HIV-1 DNA polymerase chain reaction (PCR) assay; or
- plasma HIV-1 quantitative RNA assay >1,000 copies/mL; or
- positive plasma HIV-1 RNA qualitative assay
- Subjects must have at least one documented HIV viral load that is below 200 copies/mL collected following initiation of TDF containing cART and greater than 90 days prior to randomization; no HIV 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.
- Currently being treated for at least 180 days by the time of randomization with a TDF containing cART with at least 2 other FDA approved ARVs (NOTE: This may include a TDF-containing fixed drug combination medication);
- Negative serum hepatitis B surface antigen (HBsAg) at screening or by history within 4 weeks prior to screening (see section 7.1.3);
- Willingness and ability to remain on the same cART regimen for the duration of study participation;
- Willingness and ability to participate in the study, follow all study procedures for the duration of study participation, and provide written informed consent or assent with parental permission, if applicable; and
- For females of child-bearing potential, agreement to use a minimum of one proven-effective method of birth control and willingness to postpone pregnancy for the duration of study participation (see section 5.3.2 for permitted hormonal contraceptives)
- To be considered eligible for enrollment, an individual must not meet any of the criteria listed below at the time of randomization: NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan.
- Prior hypersensitivity to vitamin D;
- History of sarcoidosis, arteriosclerosis, renal stones, glomerulonephritis, interstitial kidney disease, nephrotic syndrome, hypercalcemia, osteoporosis and/or other bone diseases, clinical diagnosis of hypoparathyroidism or hyperparathyroidism;
- Lactation or pregnancy currently or within the past 24 weeks;
- Chemotherapy or radiation therapy for malignancy within the past 12 months;
- Known presence of GI disease that, in the opinion of the clinician, would interfere with study agent administration or absorption (e.g. Crohn's, Colitis);
- For subjects ≥ 18 years, confirmed creatinine clearance < 70 ml/min (estimated glomerular filtration rate (GFR) from SCr using Cockcroft and Gault (CG) equation) and for subjects <18 years, confirmed creatinine clearance < 70ml/min/1.73m2 (estimated GFR from SCr using Schwartz formula (see section 3.5). (Estimated GFR may be calculated using the formulae programmed on the ATN website);
- SCa > Upper Limit Normal (ULN) for local laboratory values (see section 7.1.3);
- Active Grade 3 or higher clinical or laboratory toxicity except atazanavir (ATV) associated indirect hyperbilirubinemia (see section 18.104.22.168);
- Weight is > 350 pounds (lbs) or 159 kilograms (kgs);
- Positive hepatitis C antibody by history or at screening (see section 7.1.3); and
- Use of any medications as specified in sections 5.3.1, 5.3.3 and 5.4.
- Females Only: Use of certain hormonal contraceptives as specified in the protocol.
Please contact Susana Sanchez to learn more about where you can participate in this trial. Please use the contact form on the right side.