Thus, it is suspected that augmenting the GH axis in patients with HIV-associated lipodystrophy results in improved utilization of fat stores and subsequent redistribution of adipose tissue [9]. GH axis drugs investigated for the treatment of HIV-associated lipodystrophy include recombinant growth hormone (GH), growth FK506 cost hormone releasing hormone (GHRH), tesamorelin, also known as growth hormone releasing factor (GHRF), and insulin-like growth factor-1 (IGF-1). There are some concerns with this class of drug. GH, the most studied GH axis drug, costs approximately $52 per milligram, and is estimated to cost approximately US$10 000–US$30 000

per year of treatment [10]. Significant treatment-associated side effects of these drugs include arthralgias, myalgias, peripheral oedema,

insulin resistance and diabetes [11]. Considering the expense and side effects associated with these drugs, it is important to evaluate the evidence regarding the efficacies of these treatments to allow the patient and health care provider to make informed decisions. In the present systematic review, we evaluate randomized controlled trials comparing the effects of GH axis treatments with those of placebo in changing VAT, subcutaneous adipose tissue (SAT) and lean body mass (LBM) in patients with GW-572016 in vitro HIV-associated lipodystrophy. A detailed protocol was written prior to conducting the review. The protocol and documentation of all changes made after construction of the protocol are available upon request. Inclusion criteria were as follows (all were required to be met): (1) the study design must be a randomized controlled trial; (2) study participants were adult patients with HIV-associated lipodystrophy;

(3) the intervention was a GH axis drug (GH, GHRH, tesamorelin or IGF-1); (4) the comparison group was treated with placebo; and (5) the study included one of the primary outcomes. There were no exclusion criteria. Our primary outcomes of interest included changes in VAT mass, SAT mass or LBM. The secondary these outcomes included changes in extremity fat, levels of fasting plasma glucose, high-density lipoprotein (HDL) cholesterol and triglycerides, and waist circumference. Potential harms of treatment were also evaluated. The following databases were searched for studies: OVID MEDLINE (1996 to present; accessed 6 June 2010), The Cochrane Library [Cochrane Central Register of Controlled Trials and Cochrane Database of Randomized Controlled Trials (CENTRAL); accessed 11 October 2009], Web of Science (accessed 11 October 2009), Summons (accessed 13 October 2009), Google Scholar (accessed 11 October 2009) and PubMed (accessed 5 June 2010). Search terms included: HIV, AIDS, growth hormone, Serostim, GH releasing hormone, tesamorelin, IGF-1, HIV-associated lipodystrophy, adipose tissue and body composition. A comprehensive list of all search terms is available upon request.