Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions

AIDS Care - Psychological and Socio-Medical Aspects of AIDS/HIV

Volumn 24, Issue 6, 2012, Pages 769-777

  Yehia, Baligh R ^a   Long, Judith A ^a,b   Stearns, Cordelia R ^a   French, Benjamin ^a   Tebas, Pablo ^a   Frank, Ian ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

clinical outcomes; clinical trials; HIV; patient perceptions; transitions in care

Indexed keywords

ABACAVIR; ANTIRETROVIRUS AGENT; ATAZANAVIR; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; NELFINAVIR; RITONAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ADULT; ANTIVIRAL THERAPY; ARTICLE; CD4 LYMPHOCYTE COUNT; COHORT ANALYSIS; DRUG TREATMENT FAILURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MEDICAL CARE; PATIENT ATTITUDE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; RISK FACTOR; SEMI STRUCTURED INTERVIEW; TREATMENT OUTCOME;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; COHORT STUDIES; COST-BENEFIT ANALYSIS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HIV SEROPOSITIVITY; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PERCEPTION; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; UNITED STATES; VIRAL LOAD;

EID: 84861497506     PISSN: 09540121     EISSN: 13600451     Source Type: Journal    
DOI: 10.1080/09540121.2011.630368     Document Type: Article

References (42)

1. Berg, M.B., Safren, S.A., Mimiaga, M.J., Grasso, C., Boswell, S., and, Mayer, K.H. 2005. Nonadherence to medical appointments is associated with increased plasma HIV RNA and decreased CD4 cell counts in a community-based HIV primary care clinic. AIDS Care, 17 (7): 902-907. (Pubitemid 41284703)
2. Braunholtz, D.A., Edwards, S.J., and, Lilford, R.J. 2001. Are randomized clinical trials good for us (in the short term)? Evidence for a trial effect. Journal of Clinical Epidemiology, 54 (3): 217-224. (Pubitemid 32162034)
3. Daar, E.S., Tierney, C., Fischl, M.A., Sax, P.E., Mollan, K., Budhathoki, C., and, Collier, A.C. 2011. Atazanavir Plus Ritonavir or Efavirenz as Part of a 3-Drug Regimen for Initial Treatment of HIV-1: A Randomized Trial. Annals of Internal Medicine, 154 (7): 445-456.
4. Davalos, D.M., Hlaing, W.M., Kim, S., and, de la Rosa, M. 2010. Recent trends in hospital utilization and mortality for HIV infection: 2000-2005. Journal of the National Medical Association, 102 (12): 1131-1138.
5. Deeks, S.G., Hecht, F.M., Swanson, M., Elbeik, T., Loftus, R., Cohen, P.T., and, Grant, R. M. 1999. HIV RNA and CD4 cell count response to protease inhibitor therapy in an urban AIDS clinic: Response to both initial and salvage therapy. AIDS, 13 (6): F35-F43.
6. DeFreitas, D. 2010. Race and HIV clinical trial participation. Journal of the National Medical Association, 102 (6): 493-499.
7. DHHS. 2011. Panel on antiretroviral guidelines for adults and adolescents. guidelines for the use of antiretroviralagents in HIV-1-infected adults and adolescents. Retrieved from http://www.aidsinfo.nih.gov/Content Files/AdultandAdolescentGL.pdf
8. Escobar, I., Campo, M., Martin, J., Fernandez-Shaw, C., Pulido, F., and, Rubio, R. 2003. Factors affecting patient adherence to highly active antiretroviral therapy. The Annals of Pharmacotherapy, 37 (6): 775-781. (Pubitemid 36618359)
9. Fleishman, J.A., Yehia, B.R., Moore, R.D., and, Gebo, K.A. 2010. The economic burden of late entry into medical care for patients with HIV infection. Medical Care, 48 (12): 1071-1079.
10. Flexner, C. 2007. HIV drug development: The next 25 years. Nature Reviews of Drug Discovery, 6 (12): 959-966. (Pubitemid 350201786)
11. Flexner, C., Tierney, C., Gross, R., Andrade, A., Lalama, C., Eshleman, S.H., and, Mildvan, D. 2010. Comparison of once-daily versus twice-daily combination antiretroviral therapy in treatment-naive patients: Results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trial. Clinical Infectious Diseases, 50 (7): 1041-1052.
12. French, B., and, Heagerty, P.J. 2008. Analysis of longitudinal data to evaluate a policy change. Statistics in Medicine, 27 (24): 5005-5025.
13. Garcia de Olalla, P., Knobel, H., Carmona, A., Guelar, A., Lopez-Colomes, J.L., and, Cayla, J.A. 2002. Impact of adherence and highly active antiretroviral therapy on survival in HIV-infected patients. Journal of Acquired Immune Deficiency Syndrome, 30 (1): 105-110. (Pubitemid 34506694)
14. Gifford, A.L., Bormann, J.E., Shively, M.J., Wright, B.C., Richman, D.D., and, Bozzette, S.A. 2000. Predictors of self-reported adherence and plasma HIV concentrations in patients on multidrug antiretroviral regimens. Journal of Acquired Immune Deficiency Syndrome, 23 (5): 386-395. (Pubitemid 30431595)
15. Gifford, A.L., Cunningham, W.E., Heslin, K.C., Andersen, R.M., Nakazono, T., Lieu, D.K., and, Bozzette, S. A. 2002. Participation in research and access to experimental treatments by HIV-infected patients. New England Journal of Medicine, 346 (18): 1373-1382. (Pubitemid 34754611)
16. Giordano, T.P., Gifford, A.L., White, A.C. Jr, Suarez-Almazor, M.E., Rabeneck, L., Hartman, C. 2007. Retention in care: A challenge to survival with HIV infection. Clinical Infectious Diseases, 44 (11): 1493-1499. (Pubitemid 46801595)
17. Grabar, S., Pradier, C., Le Corfec, E., Lancar, R., Allavena, C., Bentata, M., and, Costagliola, D. 2000. Factors associated with clinical and virological failure in patients receiving a triple therapy including a protease inhibitor. AIDS, 14 (2): 141-149. (Pubitemid 30116439)
18. Gross, R., Tierney, C., Andrade, A., Lalama, C., Rosenkranz, S., Eshleman, S.H., and, Mildvan, D. 2009. Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients: A randomized trial. Archives of Internal Medicine, 169 (13): 1224-1232.
19. Gulick, R.M., Mellors, J.W., Havlir, D., Eron, J.J., Gonzalez, C., McMahon, D., and, Richman, D. D. 1998. Simultaneous vs sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection: 100-week follow-up. JAMA, 280 (1): 35-41. (Pubitemid 28414994)
20. Gulick, R.M., Ribaudo, H.J., Shikuma, C.M., Lalama, C., Schackman, B.R., Meyer, W.A. III., Kuritzkes, D. R. 2006. Three-vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: A randomized controlled trial. JAMA 296 7, 769-781. (Pubitemid 44223101)
21. Gulick, R.M., Ribaudo, H.J., Shikuma, C.M., Lustgarten, S., Squires, K.E., Meyer, W.A. III., 3rd., Kuritzkes, D. R. 2004. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. New England Journal of Medicine 350 18, 1850-1861 (Pubitemid 38917251)
22. Gwadz, M.V., Colon, P., Ritchie, A.S., Leonard, N.R., Cleland, C.M., Riedel, M., and, Mildvan, D. 2010. Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Current HIV/AIDS Reports, 7 (4): 194-200.
23. Hogg, R., Yip, B., Chan, K., OShaughnessy, M., &, Montaner, J. January 30-February 2 2000. Nonadherence to triple combination therapy is predictive of AIDS progression and death in HIV-positive men and women (abstract 73). Paper presented at the program and abstracts of the 7th conference on retroviruses and opportunistic infections. San Francisco, California:.
24. Knobel, H., Carmona, A., Lopez, J.L., Gimeno, J.L., Saballs, P., Gonzalez, A. 1999. Adherence to very active antiretroviral treatment: Impact of individualized assessment. Enfermedades Infecciosas y Microbiologfa Clinica, 17 (2): 78-81. (Pubitemid 29129643)
25. Lucas, G.M., Chaisson, R.E., and, Moore, R.D. 1999. Highly active antiretroviral therapy in a large urban clinic: Risk factors for virologic failure and adverse drug reactions. Annals of Internal Medicine, 131 (2): 81-87. (Pubitemid 29340558)
26. Mocroft, A., Gill, M.J., Davidson, W., and, Phillips, A.N. 1998. Predictors of a viral response and subsequent virological treatment failure in patients with HIV starting a protease inhibitor. AIDS, 12 (16): 2161-2167. (Pubitemid 28495270)
27. Nachega, J.B., Hislop, M., Dowdy, D.W., Chaisson, R.E., Regensberg, L., and, Maartens, G. 2007. Adherence to nonnucleoside reverse transcriptase inhibitor-based HIV therapy and virologic outcomes. Annals of Internal Medicine, 146 (8): 564-573. (Pubitemid 351650537)
28. Oh, D.L., Sarafian, F., Silvestre, A., Brown, T., Jacobson, L., Badri, S., and, Detels, R. 2009. Evaluation of adherence and factors affecting adherence to combination antiretroviral therapy among White, Hispanic, and Black men in the MACS Cohort. Journal of Acquired Immune Deficiency Syndrome, 52 (2): 290-293.
29. Paredes, R., Mocroft, A., Kirk, O., Lazzarin, A., Barton, S.E., van Lunzen, J., and, Clotet, B. 2000. Predictors of virological success and ensuing failure in HIV-positive patients starting highly active antiretroviral therapy in Europe: Results from the EuroSIDA study. Archives of Internal Medicine, 160 (8): 1123-1132. (Pubitemid 30227022)
30. Paterson, D.L., Swindells, S., Mohr, J., Brester, M., Vergis, E.N., Squier, C., and, Singh, N. 2000. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Annals of Internal Medicine, 133 (1): 21-30. (Pubitemid 30432540)
31. Pence, B.W., Ostermann, J., Kumar, V., Whetten, K., Thielman, N., and, Mugavero, M.J. 2008. The influence of psychosocial characteristics and race/ethnicity on the use, duration, and success of antiretroviral therapy. Journal of Acquired Immune Deficiency Syndrome, 47 (2): 194-201. (Pubitemid 351172186)
32. Phillips, A.N., Staszewski, S., Weber, R., Kirk, O., Francioli, P., Miller, V., and, Ledergerber, B. 2001. HIV viral load response to antiretroviral therapy according to the baseline CD4 cell count and viral load. JAMA, 286 (20): 2560-2567. (Pubitemid 33096807)
33. Powderly, W.G., Saag, M.S., Chapman, S., Yu, G., Quart, B., and, Clendeninn, N.J. 1999. Predictors of optimal virological response to potent antiretroviral therapy. AIDS, 13 (14): 1873-1880. (Pubitemid 29509546)
34. Riddler, S.A., Haubrich, R., DiRienzo, A.G., Peeples, L., Powderly, W.G., Klingman, K.L., and, Mellors, J. W. 2008. Class-sparing regimens for initial treatment of HIV-1 infection. New England Journal of Medicine, 358 (20): 2095-2106. (Pubitemid 351679596)
35. Robbins, G.K., De Gruttola, V., Shafer, R.W., Smeaton, L.M., Snyder, S.W., Pettinelli, C., and, Hirsch, M. S. 2003. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. New England Journal of Medicine, 349 (24): 2293-2303. (Pubitemid 37509737)
36. Routman, J.S., Willig, J.H., Westfall, A.O., Abroms, S.R., Varshney, M., Adusumilli, S., and, Mugavero, M. J. 2010. Comparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care. Clinical Infectious Diseases, 50 (4): 574-584.
37. Saag, M., Krowles, M., Chang, Y., Chapman, S., Clendeninn, N.J., &, Viracept Cooperative Study Group. 1997. Durable effect of Viracept (nelfinavir mesylate, NFV) in triple combination therapy [abstract I-101]. Paper presented at the programs and abstracts of the 37th international conference on antimicrobial agents and chemotherapy. San Diego, California:.
38. Sax, P.E., Tierney, C., Collier, A.C., Fischl, M.A., Mollan, K., Peeples, L., and, Daar, E. S. 2009. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. New England Journal of Medicine, 361 (23): 2230-2240.
39. Shafer, R.W., Smeaton, L.M., Robbins, G.K., De Gruttola, V., Snyder, S.W., D'Aquila, R.T., and, Merigan, T. C. 2003. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. New England Journal of Medicine, 349 (24): 2304-2315. (Pubitemid 37509738)
40. Weintrob, A.C., Grandits, G.A., Agan, B.K., Ganesan, A., Landrum, M.L., Crum-Cianflone, N.F., and, Marconi, V. C. 2009. Virologic response differences between African Americans and European Americans initiating highly active antiretroviral therapy with equal access to care. Journal of Acquired Immune Deficiency Syndrome, 52 (5): 574-580.
41. Yehia, B.R., Fleishman, J.A., Gebo, K.A., Agwu, A.A. 2011. Disparities in HAART Receipt for HIV-infected Adults in Care. Paper presented at the 18th Conference on Retroviruses and Opportunistic Infections.
42. Yehia, B.R., Fleishman, J.A., Hicks, P.L., Ridore, M., Moore, R.D., and, Gebo, K.A. 2010. Inpatient health services utilization among HIV-infected adult patients in care 2002-2007. Journal of Acquired Immune Deficiency Syndrome, 53 (3): 397-404.