Effects of etravirine versus placebo on health-related quality of life in treatment-experienced HIV patients as measured by the functional assessment of human immunodeficiency virus infection (FAHI) questionnaire in the DUET trials

HIV Clinical Trials

Volumn 11, Issue 1, 2010, Pages 18-27

  Cella, David ^a   Gilet, Hélène ^b   Viala Danten, Muriel ^b   Peeters, Katrien ^c   Dubois, Dominique ^d   Martin, Silas ^e  

^a NORTHWESTERN UNIVERSITY   (United States)

^b MAPI VALUES   (United States)

^c Virco BVBA   (Belgium)

^d PVS Consultancy Bvba   (Belgium)

^e CENTOCOR INC   (United States)

Author keywords

FAHI questionnaire; Health related quality of life; HIV

Indexed keywords

ENFUVIRTIDE; ETRAVIRINE;

ADULT; AGED; ARTICLE; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FEMALE; FUNCTIONAL ASSESSMENT; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; VIRUS LOAD;

EID: 77951278665     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/hct1101-18     Document Type: Article

References (43)

1. World Health Organization. AIDS Epidemic Update 2009. www unaids org 2009. Available at: http://www.unaids.org/en/KnowledgeCentre/HIVData/ EpiUpdate/EpiUpdArchive/2009/2009epidemic-update.asp.
2. Chearskul P, Rongkavilit C, Al-Tatari H, Asmar B. New antiretroviral drugs in clinical use. Indian J Pediatr. 2006;73(4):335-341. (Pubitemid 44334849)
3. Hughes A, Barber T, Nelson M. New treatment options for HIV salvage patients: an overview of second generation PIs, NNRTIs, integrase inhibitors and CCR5 antagonists. J Infect. 2008;57(1):1-10.
4. Fauci AS. The AIDS epidemic--considerations for the 21st century. N Engl J Med. 1999;341(14):1046-1050.
5. Van Sighem AI, Van De Wiel MA, Ghani AC, et al. Mortality and progression to AIDS after starting highly active antiretroviral therapy. AIDS. 2003;17(15):2227-2236. (Pubitemid 37338896)
6. Palella FJJr, Delaney KM, Moorman AC,. Declining morbidity and mortality among patients with advanced human immunodefi ciency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998;338(13):853-860. (Pubitemid 28135961)
7. Mocroft A, Ledergerber B, Katlama C, et al. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003;362(9377):22-29. (Pubitemid 36835816)
8. Andries K, Azijn H, Thielemans T, et al. TMC125, a novel next-generation nonnucleoside reverse transcriptase inhibitor active against nonnucleoside reverse transcriptase inhibitor-resistant human immunodefi ciency virus type 1. Antimicrob Agents Chemother. 2004;48(12):4680-4686. (Pubitemid 39577672)
9. Harrigan PR, Larder BA. Extent of cross-resistance between agents used to treat human immunodefi ciency virus type 1 infection in clinically derived isolates. Antimicrob Agents Chemother. 2002;46(3):909-912.
10. Leigh Brown AJ, Frost SD, Mathews WC, et al. Transmission fi tness of drug-resistant human immunodefi ciency virus and the prevalence of resistance in the antiretroviraltreated population. J Infect Dis. 2003;187(4):683-686.
11. Grossman HA, Sullivan PS, Wu AW. Quality of life and HIV: current assessment tools and future directions for clinical practice. AIDS Read. 2003;13(12):583-587.
12. Gulick RM. Current antiretroviral therapy: an overview. Qual Life Res. 1997;6(6):471-474.
13. Montessori V, Press N, Harris M, Akagi L, Montaner JS. Adverse effects of antiretroviral therapy for HIV infection. CMAJ. 2004;170(2):229-238. (Pubitemid 38134804)
14. Ickovics JR, Meade CS. Adherence to antiretroviral therapy among patients with HIV: a critical link between behavioral and biomedical sciences. J Acquir Immune Defi c Syndr. 2002;31(Suppl 3):S98-102.
15. Cahn P, Haubrich R, Leider J, et al. Pooled 24-week results of DUET-1 and 2: TMC125 (etravirine;ETR) vs placebo in 1203 treatment-experienced HIV-1-infected patients. In: Program and abstracts from the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 2007; Chicago, IL. Abstract: H-717.
16. Lazzarin A, Campbell T, Clotet B, et al. Effi cacy and safety of TMC125 (etravirine) in treatment-experienced HIV- 1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370(9581):39-48.
17. Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370(9581):29-38. (Pubitemid 47017466)
18. Katlama C, Haubrich R, Lalezari J, et al. Effi cacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009;23(17):2289-2300.
19. Tibotec Therapeutics (via PR Newswire). FDA Approves INTELENCE (etravirine) for HIV Combination Therapy. Press release. 2008.
20. Tibotec Pharmaceuticals. Intelence (Etravirine) Receives Marketing Authorisation in the European Union for HIV Combination Therapy. Press release. 2008.
21. EuroQol--a new facility for the measurement of healthrelated quality of life. The EuroQol Group. Health Policy. 1990;16(3):199-208.
22. Cella D, McCain NL, Peterman AH, Mo F, Wolen D. Development and validation of the Functional Assessment of Human Immunodefi ciency Virus Infection (FAHI) quality of life instrument. Qual Life Res. 1996;5(4):450-463. (Pubitemid 26292721)
23. Peterman AH, Cella D, Mo F, McCain N. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Qual Life Res. 1997;6(6):572-584. (Pubitemid 27431711)
24. Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York: Academic Press; 1977.
25. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407-415. (Pubitemid 20025670)
26. Sloan JA, Cella D, Hays RD. Clinical signifi cance of patientreported questionnaire data: another step toward consensus. J Clin Epidemiol. 2005;58(12):1217-1219. (Pubitemid 41608536)
27. Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006;4:71. (Pubitemid 44649666)
28. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523-1532.
29. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical signifi cance of health status measures. Mayo Clin Proc. 2002;77(4):371-383. (Pubitemid 34260746)
30. Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of healthrelated quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics. 2006;24(8):751-765. (Pubitemid 44232104)
31. Abrams DI, Steinhart C, Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impact on quality of life. Int J STD AIDS. 2000;11(10):659-665.
32. Earthman CP, Reid PM, Harper IT, Ravussin E, Howell WH. Body cell mass repletion and improved quality of life in HIV-infected individuals receiving oxandrolone. J Parenter Enteral Nutr. 2002;26(6):357-365. (Pubitemid 35216928)
33. Sikkema KJ, Hansen NB, Meade CS, Kochman A, Lee RS. Improvements in health-related quality of life following a group intervention for coping with AIDS-bereavement among HIV-infected men and women. Qual Life Res. 2005;14(4):991-1005. (Pubitemid 40685223)
34. Dubois D, Smets E, Vangeneugden T, et al. Improved quality of life in treatment-experienced HIV patients treated with TMC114/r versus control protease inhibitors: results of POWER 1 and 2 Functional Assessment of HIV Infection (FAHI). In: Program and abstracts from the 16th International AIDS Conference; 2006; Toronto, Canada.
35. Casado A, Badia X, Consiglio E, et al. Health-related quality of life in HIV-infected naive patients treated with nelfi navir or nevirapine associated with ZDV/3TC (the COMBINE-QoL substudy). HIV Clin Trials. 2004;5(3):132-139. (Pubitemid 39136306)
36. Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen. J Acquir Immune Defi c Syndr. 2004;37(1):1140-1146. (Pubitemid 39166648)
37. Nieuwkerk PT, Gisolf EH, Colebunders R, Wu AW, Danner SA, Sprangers MA. Quality of life in asymptomatic- and symptomatic HIV infected patients in a trial of ritonavir/ saquinavir therapy. AIDS. 2000;14(2):181-187. (Pubitemid 30116444)
38. van Leth F, Conway B, Laplume H, et al. Quality of life in patients treated with first-line antiretroviral therapy containing nevirapine and/or efavirenz. Antivir Ther. 2004;9(5):721-728. (Pubitemid 39434335)
39. Badia X, Podzamczer D, Garcia M, Lopez-Lavid CC, Consiglio E. A randomized study comparing instruments for measuring health-related quality of life in HIV-infected patients. Spanish MOS-HIV and MQOL-HIV Validation Group. Medical Outcomes Study HIV Health Survey. AIDS. 1999;13(13):1727-1735. (Pubitemid 30015721)
40. Eriksson LE, Bratt GA, Sandstrom E, Nordstrom G. The two-year impact of first generation protease inhibitor based antiretroviral therapy (PI-ART) on health-related quality of life. Health Qual Life Outcomes. 2005;3:32. (Pubitemid 41522156)
41. Call SA, Klapow JC, Stewart KE, Westfall AO, Mallinger AP, DeMasi RA, Centor R, Saag MS. Health-related quality of life and virologic outcomes in an HIV clinic. Qual Life Res. 2000;9(9):977-985. (Pubitemid 32289935)
42. Murri R, Fantoni M, Del Borgo C, et al. Determinants of health-related quality of life in HIV-infected patients. AIDS Care. 2003;15(4):581-590. (Pubitemid 36871798)
43. Weinfurt KP, Willke RJ, Glick HA, Freimuth WW, Schulman KA. Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients. Med Care. 2000;38(4):404-410.