Improvements in subcutaneous fat, lipid profile, and parameters of mitochondrial toxicity in patients with peripheral lipoatrophy when stavudine is switched to tenofovir (LIPOTEST Study)

HIV Clinical Trials

Volumn 9, Issue 6, 2008, Pages 407-417

  Ribera, Esteban ^a   Paradiñeiro, José Carlos ^a   Curran, Adria ^a   Sauleda, Silvia ^a   García Arumí, Elena ^a   Castella, Eva ^a   Puiggròs, Carolina ^a   Crespo, Manuel ^a   Feijoo, Maria ^a   Diaz, Marjorie ^a   del Saz, Sara Villar ^a   Planas, Merçè ^a   Sureda, Delia ^a   Falcó, Vicenç ^a   Ocaña, Imma ^a   Pahissa, Albert ^a  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

HIV infection; Lipodystrophy; Mitochondrial toxicity; Stavudine; Switch study; Tenofovir

Indexed keywords

ABACAVIR; CHOLESTEROL; DIDANOSINE; EFAVIRENZ; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LACTIC ACID; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; NEVIRAPINE; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; SAQUINAVIR; STAVUDINE; TENOFOVIR DISOPROXIL; TRIACYLGLYCEROL;

ADULT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FRACTURE; GLUCOSE BLOOD LEVEL; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERCHOLESTEROLEMIA; HYPERLACTATEMIA; HYPERTRIGLYCERIDEMIA; LACTATE BLOOD LEVEL; LIPOATROPHY; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MITOCHONDRIAL TOXICITY; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; SIDE EFFECT; SUBCUTANEOUS FAT; TRIACYLGLYCEROL BLOOD LEVEL; UNSPECIFIED SIDE EFFECT;

ADENINE; ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; BODY COMPOSITION; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FACE; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HIV-ASSOCIATED LIPODYSTROPHY SYNDROME; HUMANS; LACTATES; LIPIDS; MALE; MIDDLE AGED; MITOCHONDRIA; PHOSPHONIC ACIDS; REVERSE TRANSCRIPTASE INHIBITORS; STAVUDINE; SUBCUTANEOUS FAT; TREATMENT OUTCOME;

EID: 62749175136     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/hct0906-407     Document Type: Article

References (40)

1. Saint-Marc T, Partisani M, Poizot-Martin I, et al. Fat distribution evaluated by computed tomography and metabolic abnormalities in patients undergoing antiretroviral therapy: Preliminary results of the LIPOCO study. AIDS. 2000;14:37-49.
2. Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med. 2005; 352:48-62.
3. John M, Nolan D, Mallal S. Antiretroviral therapy and the lipodystrophy syndrome. Antivir Ther. 2001;6:9-20.
4. Nolan D, Mallal S. Antiretroviral-therapy-associated lipoatrophy: Current status and future directions. Sex Health. 2005;2:153-163.
5. McComsey G. Update on mitochondrial toxicity of antiretrovirals and its link to lipodystrophy. AIDS Rev. 2002;4:140-147.
6. Mallal SA, John M, Moore CB, James IR, McKinnon EJ. Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection. AIDS. 2000;14:1309-1316.
7. Lewis W, Kohler JJ, Hosseini SH, et al. Antiretroviral nucleosides, deoxynucleotide carrier and mitochondrial DNA: Evidence supporting the DNA pol. gamma hypothesis. AIDS. 2006;20:675-684.
8. Hurst M, Noble S. Stavudine: An update of its use in the treatment of HIV infection. Drugs. 1999;58:919-949.
9. Pozniak AL, Gallant JE, DeJesus E, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: Virologic, immunologic, and morphologic changes - a 96-week analysis. J Acquir Immune Defic Syndr. 2006;43:535-540.
10. van Leth F, Phanuphak P, Ruxrungtham K, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: A randomised open-label trial, the 2NN Study. Lancet. 2004;363:1253-1263.
11. Joly V, Flandre P, Meiffredy V, et al. Increased risk of lipoatrophy under stavudine in HIV-1-infected patients: Results of a substudy from a comparative trial. AIDS. 2002;16: 2447-2454.
12. van der-Valk M, Casula M, Weverlingz GJ, et al. 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.
13. Lichtenstein KA. Redefining lipodystrophy syndrome: Risks and impact on clinical decision making. J Acquir Immune Defic Syndr. 2005;39:395-400.
14. Saves M, Raffi F, Capeau J, et al. Factors related to lipodystrophy and metabolic alterations in patients with human immunodeficiency virus infection receiving highly active antiretroviral therapy. Clin Infect Dis. 2002;34:1396-1405.
15. Mallon PW, Miller J, Cooper DA, Carr A. Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy. AIDS. 2003; 17:971-979.
16. Podzamczer D, Ferrer E, Sanchez P, et al. Less lipoatrophy and better lipid profile with abacavir as compared to stavudine: 96-week results of a randomized study. J Acquir Immune Defic Syndr. 2006;44:139-147.
17. Martin A, Smith DE, Carr A, et al. Reversibility of lipoatrophy in HIV-infected patients 2 years after switching from a thymidine analogue to abacavir: The MITOX Extension Study. AIDS. 2004;18:1029-1036.
18. McComsey GA, Ward DJ, Hessenthaler SM, et al. Improvement in lipoatrophy associated with highly active antiretroviral therapy in human immunodeficiency virus-infected patients switched from stavudine to abacavir or zidovudine: The results of the TARHEEL study. Clin Infect Dis. 2004;38:263-270.
19. John M, McKinnon EJ, James IR, et al. Randomized, controlled, 48-week study of switching stavudine and/or protease inhibitors to combivir/ abacavir to prevent or reverse lipoatrophy in HIV-infected patients. J Acquir Immune Defic Syndr. 2003;33:29-33.
20. Garcia-Benayas T, Blanco F, de la Cruz JJ, Soriano V, Gonzalez-Lahoz J. Replacing stavudine by abacavir reduces lactate levels and may improve lipoatrophy. AIDS. 2003; 17:921-924.
21. Carr A, Workman C, Smith DE, et al. Abacavir substitution for nucleoside analogs in patients with HIV lipoatrophy: A randomized trial. JAMA. 2002;288:207-215.
22. Moyle GJ, Baldwin C, Langroudi B, Mandalia S, Gazzard BG. A 48-week, randomized, open-label comparison of three abacavir-based substitution approaches in the management of dyslipidemia and peripheral lipoatrophy. J Acquir Immune Defic Syndr. 2003;33:22-28.
23. Birkus G, Hitchcock MJ, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with tenofovir: Comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2002;46:716-723.
24. Valdez JR, Cassetti I, Suleiman JM, et al. The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in HIV-1-infected patients: Three-year follow-up after switching therapy. HIV Clin Trials. 2007;8:381-390.
25. Milinkovic A, Martinez E, Lopez S, et al. The impact of reducing stavudine dose versus switching to tenofovir on plasma lipids, body composition and mitochondrial function in HIV-infected patients. Antivir Ther. 2007;12;407-415.
26. Moyle GJ, Sabin CA, Cartledge J, et al. A randomized comparative trial of tenofovir DF or abacavir as replacement for a thymidine analogue in persons with lipoatrophy. AIDS. 2006;20:2043-2050.
27. Murphy RL, da Silva BA, Hicks CB, et al. Seven-year efficacy of a lopinavir/ritonavir-based regimen in antiretroviral-naive HIV-1-infected patients. HIV Clin Trials. 2008;9:1-10.
28. Llibre JM, Domingo P, Palacios R, et al. Sustained improvement of dyslipidaemia in HAART-treated patients replacing stavudine with tenofovir. AIDS. 2006;20:1407-1414.
29. Martinez E, Bianchi L, Garcia-Viejo MA, Bru C, Gatell JM. Sonographic assessment of regional fat in HIV-1-infected people. Lancet. 2000;356:1412-1413.
30. Kyle UG, Bosaeus I, De Lorenzo AD, et al. Bioelectrical impedance analysis-part II: Utilization in clinical practice. Clin Nutr. 2004;23:1430-1453.
31. Lichtenstein K, Ward DJ, Moorman AC, et al. Clinical assessment of HIV-associated lipodystrophy in an ambulatory population. AIDS. 2001;15:1389-1398.
32. Crespo M, Sauleda S, Esteban JI, et al. Peginterferon alpha-2b plus ribavirin vs interferon alpha-2b plus ribavirin for chronic hepatitis C in HIV-coinfected patients. J Viral Hapat. 2007;14:228-238.
33. Benn P, Sauret V, Cartledge J, et al. Improvements in facial lipoatrophy at 48 weeks following substitution of a thymidine analog with tenofovir or abacavir: A randomised, open-label study in persons with lipoatrophy and virological suppression on HAART. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV; November 13-17, 2005; Dublin, Ireland. Abstract 8. Antivir Ther. 2005;10:L7.
34. Jones PR, Davies PS, Norgan NG. Ultrasonic measurements of subcutaneous adipose tissue thickness in man. Am J Phys Anthropol. 1986;71:359-363.
35. Asensi V, Martin-Roces E, Collazos J, et al. Association between physical and echographic fat thickness assessments and a lipodystrophy grading scale in lipodystrophic HIV patients: Practical implications. AIDS Res Hum Retroviruses. 2006;22:830-836.
36. Schwenk A, Breuer P, Kremer G, Ward L. Clinical assessment of HIV-associated lipodystrophy syndrome: Bioelectrical impedance analysis, anthropometry and clinical scores. Clin Nutr. 2001;20:243-249.
37. Martinez E, Arranz JA, Podzamczer D, et al. Efficacy and safety of NRTI's switch to tenofovir plus emtricitabine (Truvada®) vs. abacavir plus lamivudine (Kivexa®) in patients with virologic suppression receiving a lamivudine containing HAART: The BICOMBO study. In: Program and abstracts of the Fourth IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 22-25, 2007; Sydney, Australia. Abstract WESS102.
38. Mallon PW, Unemori P, Sedwell R, et al. In vivo, nucleoside reverse-transcriptase inhibitors alter expression of both mitochondrial and lipid metabolism genes in the absence of depletion of mitochondrial DNA. J Infect Dis. 2005;191: 1686-1696.
39. Galluzzi L, Pinti M, Guaraldi G, et-al. Altered mitochondrial RNA production in adipocytes from HIV-infected individuals with lipodystrophy. Antivir Ther. 2005;10 (Suppl 2): M91-99.
40. Nolan D, Hammond E, Martin A, et al. Mitochondrial DNA depletion and morphologic changes in adipocytes associated with nucleoside reverse transcriptase inhibitor therapy. AIDS. 2003;17:1329-1338.