Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: A 10-year review

Health and Quality of Life Outcomes

Volumn 11, Issue 1, 2013, Pages

  Simpson, Kit N ^a   Hanson, Kristin A ^b   Harding, Gale ^c   Haider, Seema ^d   Tawadrous, Margaret ^d   Khachatryan, Alexandra ^e   Pashos, Chris L ^b   Wu, Albert W ^f  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b Express Scripts   (United States)

^c EVIDERA   (United States)

^d PFIZER INC   (United States)

^e PHARMERIT INTERNATIONAL   (United States)

^f JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

HIV; Instrument; NNRTI; Patient reported outcome (PRO)

Indexed keywords

CYPROHEPTADINE; DELAVIRDINE; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; ETRAVIRINE; LAMIVUDINE; NELFINAVIR; NEVIRAPINE; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PLACEBO; RILPIVIRINE; STAVUDINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE;

ADULT; ANXIETY DISORDER; ARTICLE; CLINICAL ASSESSMENT TOOL; CLINICAL TRIAL (TOPIC); CONSENSUS; DEPRESSION; DIARRHEA; DISTRESS SYNDROME; DYSPNEA; EPWORTH SLEEPINESS SCALE; HAMILTON ANXIETY SCALE; HAMILTON SCALE; HEALTH SURVEY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDLINE; MENTAL DISEASE; OUTCOME ASSESSMENT; PITTSBURGH SLEEP QUALITY INDEX; POSITIVE AND NEGATIVE SYNDROME SCALE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RATING SCALE; SHORT FORM 12; SHORT FORM 36; SLEEP; SLEEP TIME; SOCIAL INTERACTION; SUICIDAL IDEATION; SYMPTOM CHECKLIST 90; TREATMENT FAILURE; UNSPECIFIED SIDE EFFECT; WELLBEING;

CLINICAL TRIALS AS TOPIC; FEMALE; HIV SEROPOSITIVITY; HIV-1; HUMANS; MALE; PATIENT OUTCOME ASSESSMENT; PATIENT PARTICIPATION; QUESTIONNAIRES; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 84884892465     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-11-164     Document Type: Article

References (39)

1. Clumeck N, Pozniak A, Raffi F. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of HIV-infected adults. HIV Med 2008, 9(2):65-71. 10.1111/j.1468-1293.2007.00533.x, 18257769.
2. Hammer SM, Eron JJ, Reiss P, Schooley RT, Thompson MA, Walmsley S, Cahn P, Fischl MA, Gatell JM, Hirsch MS, Jacobsen DM, Montaner JS, Richman DD, Yeni PG, Volberding PA. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel. JAMA 2008, 300(5):555-570. 10.1001/jama.300.5.555, 18677028.
3. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents 2011, 1-166. Department of Health and Human Services, http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf, DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents.
4. Food and Drug Administration Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2009, 74(235):65132-65133. Food and Drug Administration.
5. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents 2008, 1-139. Department of Health and Human Services, http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf, DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents.
6. European AIDS Clinical Society (EACS) Guidelines for the clinical management and treatment of HIV infected adults in Europe. Version 6 2012, EACS, http://www.eacsociety.org/Portals/0/files/pdf%20files/EacsGuidelines-v6.1-2edition.pdf, European AIDS Clinical Society (EACS).
7. Dabaghzadeh F, Ghaeli P, Khalili H, Alimadadi A, Jafari S, Akhondzadeh S, Khazaeipour Z. Cyproheptadine for prevention of neuropsychiatric adverse effects of efavirenz: a randomized clinical trial. AIDS Patient Care STDS 2013, 27(3):146-154. 10.1089/apc.2012.0410, 23442031.
8. Bucciardini R, D'Ettorre G, Baroncelli S, Ceccarelli G, Parruti G, Weimer LE, Fragola V, Galluzzo CM, Pirillo MF, Lucattini S, Bellagamba R, Francisci D, Ladisa N, Degli Antoni A, Guaraldi G, Manconi PE, Vullo V, Preziosi R, Cirioni O, Verucchi G, Floridia M. Virological failure at one year in triple-class experienced patients switching to raltegravir-based regimens is not predicted by baseline factors. Int J STD AIDS 2012, 23(7):459-463. 10.1258/ijsa.2012.011391, 22843997.
9. Lake JE, McComsey GA, Hulgan TM, Wanke CA, Mangili A, Walmsley SL, Boger MS, Turner RR, McCreath HE, Currier JS. A randomized trial of Raltegravir replacement for protease inhibitor or non-nucleoside reverse transcriptase inhibitor in HIV-infected women with lipohypertrophy. AIDS Patient Care STDS 2012, 26(9):532-540. 10.1089/apc.2012.0135, 3426192, 22823027.
10. Mosam A, Shaik F, Uldrick TS, Esterhuizen T, Friedland GH, Scadden DT, Aboobaker J, Coovadia HM. A randomized controlled trial of highly active antiretroviral therapy versus highly active antiretroviral therapy and chemotherapy in therapy-naive patients with HIV-associated Kaposi sarcoma in South Africa. J Acquir Immune Defic Syndr 2012, 60(2):150-157. 10.1097/QAI.0b013e318251aedd, 3360837, 22395672.
11. Cooper V, Moyle GJ, Fisher M, Reilly G, Ewan J, Liu HC, Horne R. Beliefs about antiretroviral therapy, treatment adherence and quality of life in a 48-week randomised study of continuation of zidovudine/lamivudine or switch to tenofovir DF/emtricitabine, each with efavirenz. AIDS Care 2011, 23(6):705-713. 10.1080/09540121.2010.534433, 21476152.
12. Nguyen A, Calmy A, Delhumeau C, Mercier I, Cavassini M, Mello AF, Elzi L, Rauch A, Bernasconi E, Schmid P, Hirschel B. A randomized cross-over study to compare raltegravir and efavirenz (SWITCH-ER study). AIDS 2011, 25(12):1481-1487. 10.1097/QAD.0b013e328348dab0, 21593661.
13. Nguyen A, Calmy A, Delhumeau C, Mercier IK, Cavassini M, Fayet-Mello A, Elzi L, Genne D, Rauch A, Bernasconi E, Hirschel B. A randomized crossover study to compare efavirenz and etravirine treatment. AIDS 2011, 25(1):57-63. 10.1097/QAD.0b013e32833f9f63, 21076278.
14. Campo RE, Cohen C, Grimm K, Shangguan T, Maa J, Seekins D. Switch from protease inhibitor- to efavirenz-based antiretroviral therapy improves quality of life, treatment satisfaction and adherence with low rates of virological failure in virologically suppressed patients. Int J STD AIDS 2010, 21(3):166-171. 10.1258/ijsa.2009.008487, 20215619.
15. Cella D, Gilet H, Viala-Danten M, Peeters K, Dubois D, Martin S. 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 Clin Trials 2010, 11(1):18-27. 10.1310/hct1101-18, 20400408.
16. Cooper V, Horne R, Gellaitry G, Vrijens B, Lange AC, Fisher M, White D. The impact of once-nightly versus twice-daily dosing and baseline beliefs about HAART on adherence to efavirenz-based HAART over 48 weeks: the NOCTE study. J Acquir Immune Defic Syndr 2010, 53(3):369-377. 10.1097/QAI.0b013e3181ccb762, 20087195.
17. Cooper DA, Heera J, Goodrich J, Tawadrous M, Saag M, Dejesus E, Clumeck N, Walmsley S, Ting N, Coakley E, Reeves JD, Reyes-Teran G, Westby M, Van Der Ryst E, Ive P, Mohapi L, Mingrone H, Horban A, Hackman F, Sullivan J, Mayer H. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis 2010, 201(6):803-813. 10.1086/650697, 20151839.
18. Regnault A, Marfatia S, Louie M, Mear I, Meunier J, Viala-Danten M. Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients. Clinical trials 2009, 6(6):574-584. 10.1177/1740774509352515, 19933717.
19. Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS 2010, 24(2):87-96. 10.1089/apc.2009.0259, 20156091.
20. DeJesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, Ebrahimi R, Maa JF, Reilly K, Ecker J, McColl D, Seekins D, Farajallah A. Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune Defic Syndr 2009, 51(2):163-174. 10.1097/QAI.0b013e3181a572cf, 19357529.
21. Potard V, Chassany O, Lavignon M, Costagliola D, Spire B. Better health-related quality of life after switching from a virologically effective regimen to a regimen containing efavirenz or nevirapine. AIDS Care 2010, 22(1):54-61. 10.1080/09540120903033250, 20390481.
22. Clifford DB, Evans S, Yang Y, Acosta EP, Ribaudo H, Gulick RM. Long-term impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals (ACTG 5097s). HIV Clin Trials 2009, 10(6):343-355. 10.1310/hct1006-343, 2958039, 20133265.
23. Gutierrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terron A, Rivero A, Lopez-Cortes LF. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med 2009, 151(3):149-156. 10.7326/0003-4819-151-3-200908040-00127, 19581631.
24. Jayaweera D, Dejesus E, Nguyen KL, Grimm K, Butcher D, Seekins DW. Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naive HIV-1-infected patients over 96 weeks. HIV Clin Trials 2009, 10(6):375-384. 10.1310/hct1006-375, 20133268.
25. Boyle BA, Jayaweera D, Witt MD, Grimm K, Maa JF, Seekins DW. Randomization to once-daily stavudine extended release/lamivudine/efavirenz versus a more frequent regimen improves adherence while maintaining viral suppression. HIV Clin Trials 2008, 9(3):164-176. 10.1310/hct0903-164, 18547903.
26. DeJesus E, Ruane P, McDonald C, Garcia F, Sharma S, Corales R, Ravishankar J, Khanlou H, Shamblaw D, Ecker J, Ebrahimi R, Flaherty J. Impact of switching virologically suppressed, HIV-1-infected patients from twice-daily fixed-dose zidovudine/lamivudine to once-daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials 2008, 9(2):103-114. 10.1310/hct0902-103, 18474495.
27. Bucciardini R, Fragola V, Massella M, Polizzi C, Mirra M, Goodall R, Carey D, Hudson F, Zajdenverg R, Floridia M. Health-related quality of life outcomes in HIV-infected patients starting different combination regimens in a randomized multinational trial: the INITIO-QoL substudy. AIDS Res Hum Retroviruses 2007, 23(10):1215-1222. 10.1089/aid.2007.0067, 17961107.
28. Lafaurie M, Collin F, Bentata M, Garre M, Leport C, Levy Y, Goujard C, Chene G, Molina JM. Switch from zidovudine- to non-zidovudine-containing regimens is associated with modest haematological improvement and no obvious clinical benefit: a substudy of the ANRS 099 ALIZE trial. J Antimicrob Chemother 2008, 62(5):1122-1129. 10.1093/jac/dkn309, 18662943.
29. Journot V, Chene G, De Castro N, Rancinan C, Cassuto JP, Allard C, Vilde JL, Sobel A, Garre M, Molina JM. Use of efavirenz is not associated with a higher risk of depressive disorders: a substudy of the randomized clinical trial ALIZE-ANRS 099. Clin Infect Dis 2006, 42(12):1790-1799. 10.1086/504323, 16705588.
30. Portsmouth SD, Osorio J, McCormick K, Gazzard BG, Moyle GJ. Better maintained adherence on switching from twice-daily to once-daily therapy for HIV: a 24-week randomized trial of treatment simplification using stavudine prolonged-release capsules. HIV Med 2005, 6(3):185-190. 10.1111/j.1468-1293.2005.00287.x, 15876285.
31. Casado A, Badia X, Consiglio E, Ferrer E, Gonzalez A, Pedrol E, Gatell JM, Azuaje C, Llibre JM, Aranda M, Barrufet P, Martinez-Lacasa J, Podzamczer D, Team CS. Health-related quality of life in HIV-infected naive patients treated with nelfinavir or nevirapine associated with ZDV/3TC (the COMBINE-QoL substudy). HIV Clin Trials 2004, 5(3):132-139. 10.1310/EACX-1RFX-41R5-VH45, 15248137.
32. Negredo E, Molto J, Munoz-Moreno JA, Pedrol E, Ribera E, Viciana P, Galindos MJ, Miralles C, Burger D, Rodriguez Fumaz C, Puig J, Gel S, Rodriguez E, Videla S, Ruiz L, Clotet B. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral therapy 2004, 9(3):335-342.
33. van Leth F, Conway B, Laplume H, Martin D, Fisher M, Jelaska A, Wit FW, Lange JM, group NNs Quality of life in patients treated with first-line antiretroviral therapy containing nevirapine and/or efavirenz. Antiviral therapy 2004, 9(5):721-728. group NNs.
34. Kallianpur AR, Hulgan T, Canter JA, Ritchie MD, Haines JL, Robbins GK, Shafer RW, Clifford DB, Haas DW. Hemochromatosis (HFE) gene mutations and peripheral neuropathy during antiretroviral therapy. AIDS 2006, 20(11):1503-1513. 10.1097/01.aids.0000237366.56864.3c, 16847405.
35. Maggiolo F, Ravasio L, Ripamonti D, Gregis G, Quinzan G, Arici C, Airoldi M, Suter F. Similar adherence rates favor different virologic outcomes for patients treated with nonnucleoside analogues or protease inhibitors. Clin Infect Dis 2005, 40(1):158-163. 10.1086/426595, 15614706.
36. Santos J, Palacios R, Lopez M, Galvez MC, Lozano F, de la Torre J, Rios MJ, Lopez-Cortes LF, Rivero A, Torres-Tortosa M, Grupo Andaluz para el Estudio de las Enfermedades I Simplicity and efficacy of a once-daily antiretroviral regimen with didanosine, lamivudine, and efavirenz in naive patients: the VESD study. HIV Clin Trials 2005, 6(6):320-328. 10.1310/1XAE-BB0W-QN5R-AJGJ, 16566083, Grupo Andaluz para el Estudio de las Enfermedades I.
37. Martinez-Picado J, Negredo E, Ruiz L, Shintani A, Fumaz CR, Zala C, Domingo P, Vilaro J, Llibre JM, Viciana P, Hertogs K, Boucher C, D'Aquila RT, Clotet B, Team SS. Alternation of antiretroviral drug regimens for HIV infection. A randomized, controlled trial. Ann Intern Med 2003, 139(2):81-89. 10.7326/0003-4819-139-2-200307150-00007, 12859157.
38. Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) CNICS Data Elements http://www.uab.edu/cnics/data-core/cnics-data-elements, Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS).
39. Kozak MS, Mugavero MJ, Ye J, Aban I, Lawrence ST, Nevin CR, Raper JL, McCullumsmith C, Schumacher JE, Crane HM, Kitahata MM, Saag MS, Willig JH. Patient reported outcomes in routine care: advancing data capture for HIV cohort research. Clin Infect Dis 2012, 54(1):141-147. 10.1093/cid/cir727, 3243652, 22042879.