Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)

Inclusion Criteria:

1. HIV-1 infection, as documented by any licensed serologic test and confirmed by a western blot or by a positive plasma HIV-1 RNA performed by any laboratory that has a CLIA certification.
2. Meets Grady IDP clinical criteria for antiretroviral therapy initiation, and subject and his/her provider are agreeable to subject initiating therapy with a regimen consisting of ATV/RTV + FTC/TDF as part of his/her routine HIV management.
3. Ambulatory men and women age ≥ 30 ≤ 50 years.
4. Ability and willingness of subject or legal guardian/representative to give written informed consent.
5. ARV drug-naïve (defined as ≤ 10 days of ART at any time prior to entry).
6. Screening HIV-1 RNA ≥ 1000 copies/mL obtained within 90 days prior to study entry by any FDA-approved test for quantifying HIV-1 RNA at any laboratory that has a CLIA certification.

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

   • Absolute neutrophil count (ANC) ≥ 500/mm3
   • Hemoglobin ≥ 8.0 g/dL
   • Platelet count ≥ 40,000/mm3
   • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≥ 3 x ULN
   • Total bilirubin ≥ 2.5 x ULN
   • Calcium ≥ 8.0 mg/dL
   • Serum vitamin D level ≥ 12ng/mL
   • CrCl ≥ 50 mL/min as estimated by the Cockcroft-Gault equation.

8. Absence of history 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 imperfecta
   • Osteomalacia
   • Osteosarcoma
   • Paget's disease
   • Postmenopausal osteoporosis
   • Rheumatoid arthritis
   • Systemic lupus erythematosus
   • Thyroid disorders (hyper/hypothyroidism)

9. Contraception requirements

   1. Female Subjects of Reproductive Potential:

      Female subjects of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception while participating in the study. Acceptable methods of contraception include:

      • Condoms (male or female) with or without a spermicidal agent
      • Diaphragm or cervical cap with spermicide
      • Intrauterine device (IUD)
      • Hormone-based contraceptive (must contain at ≥ 35 mcg of ethinyl estradiol)
   2. Female Subjects Who Are Not of Reproductive Potential.

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Physical or biochemical evidence or a medical history of malignancy.
3. 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, other bisphosphonates).
4. Osteoporosis defined as T-score <-2.5 at the hip, or spine, or history of osteoporotic fracture.
5. Prior or current use of zoledronic acid (reclast®)
6. Recent (within the past 6 months) or planned (within the next 6 months) invasive dental procedure.
7. Known allergy/sensitivity to study drugs or their formulations or mammalian cell derived drug products.
8. Any condition that, in the opinion of the investigators, would compromise the subject's ability to participate in the study.
9. Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigators, for at least 7 days prior to study entry.
10. Requirement for any current medications that are prohibited with any study drugs. Prohibited medications must be discontinued at least 30 days prior to entry.
11. Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness.