Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01228318
Eligibility Criteria:
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 Clinical Laboratory Improvement Amendments (CLIA) certification.
2. Meets Grady Infectious Disease Program (IDP) clinical criteria for antiretroviral therapy initiation, and subject and his/her provider are agreeable to subject initiating therapy with a regimen consisting of atazanavir (ATV)/ritonavir (RTV) + emtricitabine (FTC)/tenofovir (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. Antiretroviral (ARV) drug-naïve (defined as ≤ 10 days of antiretroviral therapy (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 upper limit of normal (ULN)
* Total bilirubin ≥ 2.5 x ULN
* Calcium ≥ 8.0 mg/dL
* Serum vitamin D level ≥ 12ng/mL
* Creatinine clearance (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT01228318
Study Brief:
Protocol Section:
NCT01228318