State of the science conference initiative to decrease cardiovascular risk and increase quality of care for patients living with HIV/AIDS executive summary

Circulation

Volumn 118, Issue 2, 2008, Pages 198-210

  Grinspoon, Steven K ^a   Grunfeld, Carl ^a   Kotler, Donald P ^a   Currier, Judith S ^a   Lundgren, Jens D ^a   Dubé, Michael P ^a   Lipshultz, Steven E ^a   Hsue, Priscilla Y ^a   Squires, Kathleen ^a   Schambelan, Morris ^a   Wilson, Peter W F ^a   Yarasheski, Kevin E ^a   Hadigan, Colleen M ^a   Stein, James H ^a   Eckel, Robert H ^a  

^a NONE

Author keywords

Aha Conference Proceedings; AIDS; Antiretroviral therapy; Cardiovascular diseases; Highly active; HIV; Myocardial infarction; Protease inhibitors

Indexed keywords

ANTILIPEMIC AGENT; ANTIRETROVIRUS AGENT; EFAVIRENZ; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INDINAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANTHROPOMETRY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL ASSESSMENT; CONFERENCE PAPER; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INSULIN RESISTANCE; ISCHEMIC HEART DISEASE; PATIENT CARE; PRIORITY JOURNAL; RISK FACTOR; SCREENING; SIDE EFFECT; TRIACYLGLYCEROL BLOOD LEVEL; UNSPECIFIED SIDE EFFECT; HEALTH CARE QUALITY; MEDICAL SOCIETY; RISK; UNITED STATES;

ACQUIRED IMMUNODEFICIENCY SYNDROME; AMERICAN HEART ASSOCIATION; CARDIOVASCULAR DISEASES; HIV INFECTIONS; HUMANS; QUALITY OF HEALTH CARE; RISK; UNITED STATES;

EID: 47649098334     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.107.189622     Document Type: Conference Paper

References (71)

1. Friis-Møller N, Sabin CA, Weber R, d'Arminio Monforte A, El-Sadr WM, Reiss P, Thiébaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Law MG, Kirk O, Phillips AN, Lundgren JD; Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviral therapy and the risk of myocardial infarction [published correction appears in N Engl J Med. 2004;350:955]. N Engl J Med. 2003;349: 1993-2003.
2. Lohse N, Hansen AB, Pedersen G, Kronborg G, Gerstoft J, Sørensen HT, Vaeth M, Obel N. Survival of persons with and without HIV infection in Denmark, 1995-2005. Ann Intern Med. 2007;146:87-95.
3. Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med. 2005;352:48-62.
4. Hellerstein MK, Grunfeld C, Wu K, Christiansen M, Kaempfer S, Kletke C, Shackleton CH. Increased de novo hepatic lipogenesis in human immunodeficiency virus infection. J Clin Endocrinol Metab. 1993;76: 559-565.
5. Grunfeld C, Kotler DP, Shigenaga JK, Doerrler W, Tierney A, Wang J, Pierson RN Jr, Feingold KR. Circulating interferon-alpha levels and hypertriglyceridemia in the acquired immunodeficiency syndrome. Am J Med. 1991;90:154-162.
6. Grunfeld C, Pang M, Shimizu L, Shigenaga JK, Jensen P, Feingold KR. Resting energy expenditure, caloric intake, and short-term weight change in human immunodeficiency virus infection and the acquired immunodeficiency syndrome. Am J Clin Nutr. 1992;55:455-460.
7. Kotler DP, Rosenbaum K, Wang J, Pierson RN. Studies of body composition and fat distribution in HIV-infected and control subjects. J Acquir Immune Defic Syndr Hum Retrovirol. 1999;20:228-237.
8. Dubé MP, Parker RA, Tebas P, Grinspoon SK, Zackin RA, Robbins GK, Roubenoff R, Shafer RW, Wininger DA, Meyer WA III, Snyder SW, Mulligan K. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005;19:1807-1818.
9. Bacchetti P, Gripshover B, Grunfeld C, Heymsfield S, McCreath H, Osmond D, Saag M, Scherzer R, Shlipak M, Tien P; Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Fat distribution in men with HIV infection. J. Acquir Immune Defic Syndr. 2005;40:121-131.
10. Joy T, Keogh HM, Hadigan C, et al. Relationship of body composition to BMI in HIV-infected patients with metabolic abnormalities. J Acquir Immune Defic Syndr. 2008;42:174-184.
11. Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM). Fat distribution in women with HIV infection. J Acquir Immune Defic Syndr. 2006;42:562-571.
12. Grunfeld C, Rimland D, Gibert CL, Powderly WG, Sidney S, Shlipak MG, Bacchetti P, Scherzer R, Haffher S, Heymsfield SB. Association of upper trunk and visceral adipose tissue with insulin resistance in control and HIV-infected subjects in the FRAM study. J Acquir Immun Def Syndr. 2007;46:283-290.
13. Purnell JQ, Zambon A, Knopp RH, Pizzuti DJ, Achari R, Leonard JM, Locke C, Brunzell JD. Effect of ritonavir on lipids and post-heparin lipase activities in normal subjects. AIDS. 2000;14:51-57.
14. Riddler SA, Smit E, Cole SR, Li R, Chmiel JS, Dobs A, Palella F, Visscher B, Evans R, Kingsley LA. Impact of HIV infection and HAART on serum lipids in men. JAMA. 2003;289:2978-2982.
15. Murata H, Hruz PW, Mueckler M. The mechanism of insulin resistance caused by HIV protease inhibitor therapy. J Biol Chem. 2000;275: 20251-20254.
16. Noor MA, Lo JC, Mulligan K, Schwarz JM, Halvorsen RA, Schambelan M, Grunfeld C. Metabolic effects of indinavir in healthy HIV-seronegative men. AIDS. 2001;15:F11-F18.
17. Fleischman A, Johnsen S, Systrom DM, Hrovat M, Farrar CT, Frontera W, Fitch K, Thomas BJ, Torriani M, Cote HC, Grinspoon SK. Effects of a nucleoside reverse transcriptase inhibitor, stavudine, on glucose disposal and mitochondrial function in muscle of healthy adults. Am J Physiol Endocrinol Metab. 2007;292:E1666-E1673
18. van der Valk M, Casula M, Weverlingz GJ, van Kuijk K, van Eck-Smit B, Hulsebosch HJ, Nieuwkerk P, van Eeden A, Brinkman K, Lange J, de Ronde A, Reiss P. Prevalence of lipoatrophy and mitochondrial DNA content of blood and subcutaneous fat in HIV-1-infected patients randomly allocated to zidovudine- or stavudine-based therapy. Antivir Ther. 2004;9:385-393.
19. Szczech LA, Grunfeld C, Scherzer R, Canchola JA, van der Horst C, Sidney S, Wohl D, Shlipak MG. Microalbuminuria in HIV infection. AIDS. 2007;21:1003-1009.
20. Bozzette SA, Ake C, Carpenter A, Bommakanty U, Leung V, Tarn H, Smith R, Schepps A, Louis T. Cardio- and cerebrovascular outcomes with changing process of anti-HIV therapy in 36,766 US veterans. Presented at: 9th Conference on Retroviruses and Opportunistic Infections; February 24-28, 2002; Seattle, Wash. Abstract No. LB9.
21. Currier JS, Taylor A, Boyd F, Dezii CM, Kawabata H, Burtcel B, Maa JF, Hodder S. Coronary heart disease in HIV-infected individuals. J Acquir Immune Defic Syndr. 2003;33:506-512.
22. Klein D, Hurley L, Silverberg M, Horberg M, Quesenbery C, Sidney S. Surveillance data for myocardial infarction hospitalizations among HIV+ and HIV Northern Californians: 1994-2006. Presented at: 14th Conference on Retroviruses and Opportunistic Infections; February 25-28, 2007; Los Angeles, Calif. Paper No. 807.
23. Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007; 92:2506-2512.
24. DAD Study Group, Friis-Møller N, Reiss P, Sabin CA, Weber R, Monforte A, El-Sadr W, Thiébaut R, De Wit S, Kirk O, Fontas E, Law MG, Phillips A, Lundgren JD. Class of antiretroviral drugs and the risk of myocardial infarction. N Engl J Med. 2007;356:1723-1735.
25. El-Sadr W, Reiss P, De Wit S, Monforte AD, Thiébaut R, Morfeldt L, Weber R, Pradier C, Calvo G, Law M, Kirk O, Sabin C, Friis-Møller N, Lundgren J; on behalf of the DAD Study Group. Relationship between prolonged exposure to combination ART and myocardial infarction: effect of sex, age, and lipid changes. Presented at: 12th Conference on Retroviruses and Opportunistic Infections; February 22-25, 2005; Boston, Mass. Page 80. Paper No. 42.
26. Savès M, Chêne G, Ducimetière P, Leport C, Le Moal G, Amouyel P, Arveiler D, Ruidavets JB, Reynes J, Bingham A, Raffi F; French WHO MONICA Project and the APROCO (ANRS EP11) Study Group. Risk factors for coronary heart disease in patients treated for human immunodeficiency virus infection compared with the general population. Clin Infect Dis. 2003;37:292-298.
27. Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren JD, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006;355:2283-2296.
28. Lewis W. Cardiomyopathy in AIDS: a pathophysiological perspective. Prog Cardiovasc Dis. 2000;43:151-170.
29. Barbaro G, Di Lorenzo G, Grisorio B, Barbarini G; Gruppo Italiano per lo Studio Cardiologico dei pazienti affetti da AIDS Investigators. Cardiac involvement in the acquired immunodeficiency syndrome: a multicenter clinical-pathological study. AIDS Res Hum Retroviruses. 1998;14: 1071-1077.
30. Herskowitz A, Wu TC, Willoughby SB, Vlahov D, Ansari AA, Beschorner WE, Baughman KL. Myocarditis and cardiotropic viral infection associated with severe left ventricular dysfunction in late-stage infection with human immunodeficiency virus. J Am Coll Cardiol. 1994; 24:1025-1032.
31. Lipshultz SE, Easley KA, Orav EJ, Kaplan S, Stare TJ, Bricker JT, Lai WW, Moodie DS, Sopko G, Colan SD; Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection (P2C2 HIV) Study Group. Cardiac dysfunction and mortality in HIV-infected children: the Prospective P2C2 HIV Multicenter Study. Circulation. 2000;102:1542-1548.
32. Fisher SD, Easley KA, Orav EJ, Colan SD, Kaplan S, Stare TJ, Bricker JT, Lai WW, Moodie DS, Sopko G, Lipshultz SE; Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2 HIV) Study Group. Mild dilated cardiomyopathy and increased left ventricular mass predict mortality: the prospective P2C2 HIV Multicenter Study. Am Heart J. 2005;150:439-447.
33. Al-Attar I, Orav EJ, Exil V, Vlach SA, Lipshultz SE. Predictors of cardiac morbidity and related mortality in children with acquired immunodeficiency syndrome. J Am Coll Cardiol. 2003;41:1598-1605.
34. Lipshultz SE, Orav EJ, Sanders SP, Colan SD. Immunoglobulins and left ventricular structure and function in pediatric HIV infection. Circulation. 1995;92:2220-2225.
35. Ren Z, Yao Q, Chen C. HIV-1 envelope glycoprotein 120 increases intercellular adhesion molecule-1 expression by human endothelial cells. Lab Invest. 2002;82:245-255.
36. Conaldi PG, Serra C, Dolei A, Basolo F, Falcone V, Mariani G, Speziale P, Toniolo A. Productive HIV-1 infection of human vascular endothelial cells requires cell proliferation and is stimulated by combined treatment with interleukin-1 beta plus tumor necrosis factor-alpha. J Med Virol. 1995;47:355-363.
37. Seoane L, Shellito J, Welsh D, de Boisblanc BP. Pulmonary hypertension associated with HIV infection. South Med J. 2001;94:635-639.
38. Nunes H, Humbert M, Sitbon O, Morse JH, Deng Z, Knowles JA, Le Gall C, Parent F, Garcia G, Hervé P, Barst RJ, Simonneau G. Prognostic factors for survival in human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med. 2003; 167: 1433-1439.
39. Harmon WG, Dadlani GH, Fisher SD, Lipshultz SE. Myocardial and pericardial disease in HIV. Curr Treat Options Cardiovasc Med. 2002; 4:497-509.
40. Lewis W, Kohler JJ, Hosseini SH, Haase CP, Copeland WC, Bienstock RJ, Ludaway T, McNaught J, Russ R, Stuart T, Santoianni R. Antiret-roviral nucleosides, deoxynucleotide carrier and mitochondrial DNA: evidence supporting the DNA pol gamma hypothesis. AIDS. 2006;20: 675-684.
41. Miller TL, Easley KA, Zhang W, Orav EJ, Bier DM, Luder E, Ting A, Shearer WT, Vargas JH, Lipshultz SE; Pediatric Pulmonary and Cardio-vascular Complications of Vertically Transmitted HIV Infection (P2C2 HIV) Study Group. Maternal and infant factors associated with failure to thrive in children with vertically transmitted human immunodeficiency virus-1 infection: the prospective, P2C2 human immunodeficiency virus multicenter study. Pediatrics. 2001;108:1287-1296.
42. Shankar SS, Dubé MP, Gorski JC, Klaunig JE, Steinberg HO. Indinavir impairs endothelial function in healthy HIV-negative men. Am Heart J. 2005;150:933.
43. Fu W, Chai H, Yao Q, Chen C. Effects of HIV protease inhibitor ritonavir on vasomotor function and endothelial nitric oxide synthase expression. J Acquir Immune Defic Syndr. 2005;39:152-158.
44. Baliga RS, Liu C, Hoyt DG, Chaves AA, Bauer JA. Vascular endothelial toxicity induced by HIV protease inhibitor: evidence of oxidant-related dysfunction and apoptosis. Cardiovasc Toxicol. 2004;4:199-206.
45. Wang X, Chai H, Yao Q, Chen C. Molecular mechanisms of HIV protease inhibitor-induced endothelial dysfunction. J Acquir Immune Defic Syndr. 2007;44:493-499.
46. Dressman J, Kincer J, Matveev SV, Guo L, Greenberg RN, Guerin T, Meade D, Li XA, Zhu W, Uittenbogaard A, Wilson ME, Smart EJ. HIV protease inhibitors promote atherosclerotic lesion formation independent of dyslipidemia by increasing CD36-dependent cholesteryl ester accumulation in macrophages. J Clin Invest. 2003;111:389-397.
47. Sutliff RL, Dikalov S, Weiss D, Parker J, Raidel S, Racine AK, Russ R, Haase CP, Taylor WR, Lewis W. Nucleoside reverse transcriptase inhibitors impair endothelium-dependent relaxation by increasing superoxide. Am J Physiol Heart Circ Physiol. 2002;283:H2363-H2370.
48. Aberg JA, Gallant JE, Anderson J, Oleske JM, Libman H, Currier JS, Stone VE, Kaplan JE; HIV Medicine Association of the Infectious Diseases Society of America. Primary care guidelines for the management of persons infected with human immunodeficiency virus: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2004;39:609-629.
49. Friis-Moller N, Thiebaut R, Reiss P, El-Sadr W, Worm S, Kirk O, Phillips A, Sabin C, Lundgren J, Law M; the D:A:D Study Group. Predicting the risk of coronary heart disease in HIV-infected patients: the D:A:D: risk equation. Presented at: 14th Conference on Retroviruses and Opportunistic Infections; February 25-28, 2007; Los Angeles, Calif. Paper No. 808.
50. Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998;97:1837-1847.
51. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421.
52. US Preventive Services Task Force. Screening for coronary heart disease: recommendations statement. Ann Intern Med. 2004;140:569-572.
53. Pearson TA, Mensah GA, Alexander RW, Anderson JL, Cannon RO III, Criqui M, Fadl YY, Fortmann SP, Hong Y, Myers GL, Rifai N, Smith SC Jr, Taubert K, Tracy RP, Vinicor F; Centers for Disease Control and Prevention; American Heart Association. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: a statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003;107:499-511.
54. Feldman JG, Goldwasser P, Holman S, DeHovitz J, Mikoff H. C-reactive protein is an independent predictor of mortality in women with HIV-1 infection. J Acquir Immune Defic Syndr. 2003;32:210-214.
55. Tong Q, Sankale JL, Hadigan CM, Tan G, Rosenberg ES, Kanki PJ, Grinspoon SK, Hotamisligil GS. Regulation of adiponectin in human immunodeficiency virus-infected patients: relationship to body composition and metabolic indices. J Clin Endocrinol Metab. 2003;88: 1559-1564.
56. Sattar N, Williams K, Sniderman AD, D'Agostino R Jr, Haffher SM. Comparison of the associations of apolipoprotein B and non-high-density lipoprotein cholesterol with other cardiovascular risk factors in patients with the metabolic syndrome in the Insulin Resistance Atherosclerosis Study. Circulation. 2004;110:2687-2693.
57. Hsue PY, Lo JC, Franklin A, Bolger AF, Martin JN, Deeks SG, Waters DD. Progression of atherosclerosis as assessed by carotid intima-media thickness in patients with HIV infection. Circulation. 2004;109: 1603-1608.
58. Mangili A, Gerrior J, Tang AM, O'Leary DH, Polak JK, Schaefer EJ, Gorbach SL, Wanke CA. Risk of cardiovascular disease in a cohort of HIV-infected adults: a study using carotid intima-media thickness and coronary artery calcium score. Clin Infect Dis. 2006;43:1482-1489.
59. Meng Q, Lima JA, Lai H, Vlahov D, Celentano DD, Strathdee SA, Nelson KE, Wu KC, Chen S, Tong W, Lai S. Coronary artery calcification, atherogenic lipid changes, and increased erythrocyte volume in black injection drug users infected with human immunodeficiency virus-1 treated with protease inhibitors. Am Heart J. 2002;144:642-648.
60. Stein JH, Klein MA, Bellehumeur JL, McBride PE, Wiebe DA, Otvos JD, Sosman JM. Use of human immunodeficiency virus-1 protease inhibitors is associated with atherogenic lipoprotein changes and endothelial dysfunction. Circulation. 2001;104:257-262.
61. Iloeje UH, Yuan Y, LTtalien G, Mauskopf J, Holmberg SD, Moorman AC, Wood KC, Moore RD. Protease inhibitor exposure and increased risk of cardiovascular disease in HIV-infected patients. HIV Med. 2005;6: 37-44.
62. Law MG, Friis-Møller N, El-Sadr WM, Weber R, Reiss P, D'Arminio Monforte A, Thiébaut R, Morfeldt L, De Wit S, Pradier C, Calvo G, Kirk O, Sabin CA, Phillips AN, Lundgren JD; D:A:D Study Group. The use of the Framingham equation to predict myocardial infarctions in HIV-infected patients: comparison with observed events in the D:A:D Study. HIV Med. 2006;7:218-230.
63. Fitch KV, Anderson EJ, Hubbard JL, Carpenter SJ, Waddell WR, Caliendo AM, Grinspoon SK. Effects of a lifestyle modification program in HIV-infected patients with the metabolic syndrome. AIDS. 2006;20: 1843-1850.
64. Joy T, Keogh HM, Hadigan C, Lee H, Dolan SE, Fitch K, Liebau J, Lo J, Johnsen S, Hubbard J, Anderson EJ, Grinspoon S. Dietary fat intake and relationship to serum lipid levels among HIV-infected subjects with metabolic abnormalities in the HAART era. AIDS. 2007;21:1591-1600.
65. Stein JH, Merwood MA, Bellehumeur JL, Aeschlimann SE, Korcarz CE, Underbakke GL, Mays ME, Sosman JM. Effects of pravastatin on lipoproteins and endothelial function in patients receiving human immunodeficiency virus protease inhibitors. Am Heart J. 2004;147:E18.
66. Falutz J, Alias S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-2370.
67. Dubé MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ; Adult AIDS Clinical Trials Group Cardiovascular Subcommittee; HIV Medical Association of the Infectious Disease Society of America. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis. 2003;37:613-627.
68. Brown IT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, Visscher BR, Margolick JB, Dobs AS. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study [published correction appears in Arch Intern Med. 2005;165:2541]. Arch Intern Med. 2005;165:1179-1184.
69. Hadigan C, Meigs JB, Corcoran C, Rietschel P, Piecuch S, Basgoz N, Davis B, Sax P, Stanley T, Wilson PW, D'Agostino RB, Grinspoon S. Metabolic abnormalities and cardiovascular disease risk factors in adults with human immunodeficiency virus infection and lipodystrophy. Clin Infect Dis. 2001;32:130-139.
70. Hadigan C, Corcoran C, Basgoz N, Davis B, Sax P, Grinspoon S. Metformin in the treatment of HIV lipodystrophy syndrome: a randomized controlled trial. JAMA. 2000;284:472-477.
71. Hadigan C, Yawetz S, Thomas A, Havers F, Sax PE, Grinspoon S. Metabolic effects of rosiglitazone in HIV lipodystrophy: a randomized, controlled trial. Ann Intern Med. 2004;140:786-794.