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

Completed

Conditions studied: HIV Infection, Osteopenia, Osteoporosis

In brief

Advances in HAART have been a huge success story in the management of HIV infection. However, serious metabolic complications including osteoporosis and bone fractures are increasingly been seen with HAART, and the responsible mechanisms remain poorly elucidated. The skeleton continually regenerates through homeostatic bone remodeling. Osteoclasts the cells responsible for bone resorption form under the influence of the key osteoclastogenic cytokine Receptor- Activator of NF-KB (RANKL). The osteoclastogenic and pro-resorptive activities of RANKL are moderated by its physiological decoy receptor osteoprotegerin (OPG). Increase in the ratio of RANKL to OPG accelerates the rate of osteoclastic bone resorption leading to osteoporosis. The investigators' preliminary studies have now demonstrated that in an animal model of HIV/AIDS, the HIV-1 Transgenic rat, the development of osteoporosis is recapitulated as observed in human patients. Furthermore, the investigators found that B cell expression of OPG is significantly downregulated, concurrent with a significant upregulation in production of RANKL.

Key facts

Study ID

NCT01020045

Run by

Emory University

People needed

120

Starts

2010-10-01

Expected to finish

2015-10-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy (sero-negative) volunteers and otherwise healthy treatment naïve HIV-1 sero-positive patient.
• 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).
• Ability and willingness of subject or legal guardian/representative to give written informed consent.
• Antiretroviral naivety.
• No CD4 T-cell counts requirement.
• 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
• 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

You may not qualify if…

• Physical or biochemical evidence or a medical history of malignancy.
• 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).
• The patient is not fully ambulatory.
• 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.

Where it is running

• Grady Infectious Diseases Program Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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