BACKGROUND: Assessments of health-related quality of life and treatment satisfaction were conducted as part of a randomised, double-blind, placebo-controlled 52-week trial conducted in Canada, Australia, Europe, and South Africa (CAESAR). The Medical Outcomes Study HIV Health Survey (MOS-HIV) was self-administered during 3 scheduled clinic visits (baseline, week 28 and the end-of-treatment/withdrawal visit). A single question was used at the end of treatment to assess patient satisfaction with study medications. METHODS: Patients were randomly allocated to receive placebo, lamivudine (150 mg twice daily) or lamivudine (150 mg twice daily) plus loviride (100 mg 3 times daily) in addition to their current treatment regimen, which could be either zidovudine monotherapy, or zidovudine in combination with didanosine or zalcitabine at standard dosages. RESULTS: Statistically significant differences across treatment groups were demonstrated for the Physical and Mental Health Summary scores, and for 5 of 10 MOS-HIV subscales (physical functioning, vitality, cognitive functioning, general health perceptions, social functioning). These differences favoured the lamivudine and lamivudine plus loviride groups over the placebo group (p < 0.05). No significant difference was found between the 3 treatment groups with regard to the percentages of patients who were satisfied with their study medication. CONCLUSION: The results suggest that, for treatment-experienced patients with HIV infection and CD4+ counts < 250 cells/mm3, the addition of lamivudine or lamivudine plus loviride to antiretroviral regimens containing zidovudine maintained patient-reported mental and physical health.
RCT Entities:
BACKGROUND: Assessments of health-related quality of life and treatment satisfaction were conducted as part of a randomised, double-blind, placebo-controlled 52-week trial conducted in Canada, Australia, Europe, and South Africa (CAESAR). The Medical Outcomes Study HIV Health Survey (MOS-HIV) was self-administered during 3 scheduled clinic visits (baseline, week 28 and the end-of-treatment/withdrawal visit). A single question was used at the end of treatment to assess patient satisfaction with study medications. METHODS:Patients were randomly allocated to receive placebo, lamivudine (150 mg twice daily) or lamivudine (150 mg twice daily) plus loviride (100 mg 3 times daily) in addition to their current treatment regimen, which could be either zidovudine monotherapy, or zidovudine in combination with didanosine or zalcitabine at standard dosages. RESULTS: Statistically significant differences across treatment groups were demonstrated for the Physical and Mental Health Summary scores, and for 5 of 10 MOS-HIV subscales (physical functioning, vitality, cognitive functioning, general health perceptions, social functioning). These differences favoured the lamivudine and lamivudine plus loviride groups over the placebo group (p < 0.05). No significant difference was found between the 3 treatment groups with regard to the percentages of patients who were satisfied with their study medication. CONCLUSION: The results suggest that, for treatment-experienced patients with HIV infection and CD4+ counts < 250 cells/mm3, the addition of lamivudine or lamivudine plus loviride to antiretroviral regimens containing zidovudine maintained patient-reported mental and physical health.
Authors: A W Wu; W C Mathews; L T Brysk; J H Atkinson; I Grant; I Abramson; C J Kennedy; J A McCutchan; S A Spector; D D Richman Journal: J Acquir Immune Defic Syndr (1988) Date: 1990
Authors: S M Hammer; K E Squires; M D Hughes; J M Grimes; L M Demeter; J S Currier; J J Eron; J E Feinberg; H H Balfour; L R Deyton; J A Chodakewitz; M A Fischl Journal: N Engl J Med Date: 1997-09-11 Impact factor: 91.245
Authors: R M Gulick; J W Mellors; D Havlir; J J Eron; C Gonzalez; D McMahon; D D Richman; F T Valentine; L Jonas; A Meibohm; E A Emini; J A Chodakewitz Journal: N Engl J Med Date: 1997-09-11 Impact factor: 91.245
Authors: A W Wu; H R Rubin; W C Mathews; L M Brysk; S A Bozzette; W D Hardy; J H Atkinson; I Grant; S A Spector; J A McCutchan Journal: J Acquir Immune Defic Syndr (1988) Date: 1993-05
Authors: Darren J Clayson; Diane J Wild; Paul Quarterman; Isabelle Duprat-Lomon; Maria Kubin; Stephen Joel Coons Journal: Pharmacoeconomics Date: 2006 Impact factor: 4.981
Authors: Ritesh N Kumar; Duane M Kirking; Steven L Hass; Amiram D Vinokur; Stephanie D Taylor; Mark J Atkinson; Patrick L McKercher Journal: Qual Life Res Date: 2007-05-26 Impact factor: 4.147
Authors: Sara Lodi; Nneka I Emenyonu; Kara Marson; Dalsone Kwarisiima; Robin Fatch; Michael G McDonell; Debbie M Cheng; Harsha Thirumurthy; Monica Gandhi; Carol S Camlin; Winnie R Muyindike; Judith A Hahn; Gabriel Chamie Journal: Trials Date: 2021-05-20 Impact factor: 2.279
Authors: Craig R Cohen; Rachel L Steinfeld; Elly Weke; Elizabeth A Bukusi; Abigail M Hatcher; Stephen Shiboski; Richard Rheingans; Kate M Scow; Lisa M Butler; Phelgona Otieno; Shari L Dworkin; Sheri D Weiser Journal: Springerplus Date: 2015-03-12
Authors: Murtuza Bharmal; Krista Payne; Mark J Atkinson; Marie-Pierre Desrosiers; Donald E Morisky; Eric Gemmen Journal: Health Qual Life Outcomes Date: 2009-04-27 Impact factor: 3.186
Authors: Mark J Atkinson; Anusha Sinha; Steven L Hass; Shoshana S Colman; Ritesh N Kumar; Meryl Brod; Clayton R Rowland Journal: Health Qual Life Outcomes Date: 2004-02-26 Impact factor: 3.186