Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART
HIV Infection
About this trial
This is an interventional diagnostic trial for HIV Infection
Eligibility Criteria
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.
Sites / Locations
- Children's Hopsital of Los Angeles
- University of Southern California - NICHD Westat Site
- Childrens National Medical Center
- Children's Diagnostic and Treatment Center - NICHD Westat Site
- University of Miami School of Medicine
- University of South Florida
- Stroger Hospital and the CORE Center
- Tulane Medical Center
- Johns Hopkins University - NICHD Westat Site
- Johns Hopkins University
- Fenway Institute
- Wayne State University
- Montefiore Medical Center
- Children's Hospital of Philadelphia
- St. Jude Childrens Research Hospital
- Baylor College of Medicine
- San Juan City Hospital (Puerto Rico) - NICHD Westat Site
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group A: Vitamin D3 50,000 IU
Group B: Vitamin D3 placebo
Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.
Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.