Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safe and Effective Vitamin D Supplementation in HIV
Brief Summary: Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.


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 perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y
3. Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 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)
5. Subject and/or family commitment to the 3-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 D supplementation (subjects willing to discontinue supplementation will become eligible after a 2-month washout period)
5. Baseline elevated serum calcium concentration
6. Non-English speaking
C: Inclusion Criteria:

* Age ≥18 years
* Documented HIV infection
* Subjects must have taken HAART 6 months prior to study entry and must be on stable HAART (no dose change to antiretroviral medications) for at least 30 days immediately prior to study entry
* HDL \< 40 mg/dL • LDL \< 130 mg/dL
* All subjects with reproductive potential should utilize adequate contraception for the duration of this study and for at least 12 weeks following permanent discontinuation of study treatment. Acceptable methods include male condom, female condom, diaphragm, or intra-uterine device (IUD)

Exclusion Criteria:

* Known cardiac disease
* Arrhythmia
* History of angina
* Uncontrolled hypertension
* Pregnancy
* Breast-feeding
* Medication known to influence vasodilatation such as nitrates, metformin, pioglitazone, and rosiglitazone
* Heavy use of vitamin supplements
* Diagnosis of diabetes mellitus
* Treatment with lipid-lowering drugs within 6 weeks prior to study
* Hemoglobin \<9.0 mg/dL
* Absolute neutrophil count \<750 cells/mm3
* Platelet count \<75,000 platelets/ mm3
* Alanine aminotransferase (ALT or SGOT)/ aspartate aminotransferase (AST or SGPT) / alkaline phosphatase \> 2.5 x upper limit of normal (ULN)
* Creatinine \>1.5 x ULN
* Individuals with an infection or other medical illness requiring hospitalization within 14 days prior to study entry
* Individuals who have active alcohol or drug abuse which, in the investigator's opinion, is sufficient to prevent adequate compliance with study therapy and evaluations
* Prior history of hypersensitivity reaction to niacin or any other component of the study drug
D: Inclusion Criteria:

* HIV infected
* Drug User
* Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml

Exclusion Criteria:

* Currently participating in an another clinical trial
* Blood selenium level less than 85 mcg/L
* Pregnant or intends to become pregnant

Answer: B