Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
Brief Summary: We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo.

The specific aims of this project are to:

1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.

   We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo.
2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.

   We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo
3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.

We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.


Options:
A: 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.
B: Inclusion Criteria:

1. HIV seropositive diagnosed with standard techniques
2. Age for PA Group: 5.0 to 24.9 y
3. Age for BA Group: 15.0 to 24.9 y
4. In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
5. Subject and/or family commitment to the 12-month study

Exclusion Criteria:

1. Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
2. Pregnancy
3. Participation in another HIV intervention study with impact on 25D serum concentrations
4. Use of vit D3 supplementation for the purpose of treating vit D deficiency
5. Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
6. Non-English Speaking
C: Inclusion Criteria:

Subject, parent, or legal guardian able and willing to provide informed consent/assent.

Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymerase chain reaction or HIV culture performed at any age; 2) Age \>18 months, licensed ELISA with confirmatory Western Blot.

Exclusion Criteria:

Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease.

Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir
D: Inclusion Criteria:

* Men and women, age 18 to 60 years inclusive
* At least two positive sputum smears for tuberculosis
* Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
* Subjects who grant informed consent to participation

Exclusion Criteria:

* Karnofsky score \< 40%
* Hemoglobin \< 8.5 g/dl
* Having had treatment for TB exceeding 4 weeks in the last 5 years
* Pregnant women

Answer: C