Effect of HIV Infection and Highly Active Antiretroviral Treatment (HAART) on Bone Homeostasis (OPG-2)

Healthy (HIV sero-negative) volunteers and otherwise healthy antiretroviral treatment naïve HIV-1 sero-positive patients, age >18 years.

Inclusion Criteria:

1. Healthy (sero-negative) volunteers and otherwise healthy treatment naïve HIV-1 sero-positive patient.
2. Age >30<50 years and segregated into age and gender ranges as described above in section 3.2 (15 subjects per stratification based on Power Test).
3. Ability and willingness of subject or legal guardian/representative to give written informed consent.
4. Antiretroviral naivety.
5. No CD4 T-cell counts requirement.

6. Absence of non-HIV related active immunological or bone disorders such as;

   • Bone marrow or organ transplantation
   • Inflammatory bowel disease (ulcerative colitis, crohn's disease)
   • Multiple Myeloma
   • Osteogenesis imperfect
   • Osteomalacia
   • Osteosarcoma
   • Paget's disease
   • Postmenopausal osteoporosis
   • Rheumatoid arthritis
   • Systemic lupus erythematosus

7. Laboratory values obtained within 90 days prior to study entry:

   • Hemoglobin >9.4 g/dl
   • Creatinine < 2 mg/dl
   • AST (SGOT) < 2 x ULN
   • ALT (SGPT) < 2 x ULN

Exclusion Criteria:

1. Physical or biochemical evidence or a medical history of malignancy.
2. Currently (within the past 8 weeks) taking any medication with known influence on the immune or skeletal system (e.g. immune modulation therapy, glucocorticoids, steroid hormones, bisphosphonates).
3. The patient is not fully ambulatory.
4. Pregnancy or breast feeding.

Exclusion criteria are primarily centered on immunological aspects with bone related aspects secondary. This is because in our model immunological function is proximal to bone function. Consequently, use of vitamin D or calcium supplementation will not be exclusion criteria, but will be added as covariates in our analysis.