Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART

This is an interventional diagnostic trial for HIV Infection Read More

Inclusion 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)

Exclusion Criteria:

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 9.5.2.2);
• 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.