LONGITUDINAL-STUDY ON THE QUALITY-OF-LIFE OF SYMPTOMATIC HIV-INFECTEDPATIENTS IN A TRIAL OF ZIDOVUDINE VERSUS ZIDOVUDINE AND INTERFERON-ALPHA

Objectives: To compare the effect of treatment with zidovudine (ZDV) o r a combination of ZDV and interferon-alpha (IFN-alpha) on patient Qua lity-of-Life (QoL); and to document changes over time in QoL. Design: This study is part of a longitudinal, randomized, controlled clinical trial comparing the efficacy and tolerance of ZDV monotherapy and ZDV plus IFN-alpha. Patients were followed-up for 1 year. Setting: Seven a cademic or general medical hospitals. Participants: Thirty-six symptom atic HIV-infected patients (Centers for Disease Control and Prevention stage IV) with a CD4+ count greater-than-or-equal-to 150 x 10(6)/l an d Karnofsky Performance Status score greater-than-or-equal-to 60, who had not received ZDV or IFN-alpha before. Methods: QoL was assessed us ing two self-report questionnaires (the European Organization for Rese arch and Treatment of Cancer Core Quality-of-Life Questionnaire and an AIDS-specific questionnaire), administered before and every 3 months after the start of the treatment. Results: There were no significant d ifferences in QoL between the two treatment groups over a 1-year perio d. Emotional, cognitive and social functioning improved in the entire group, and patients reported fewer symptoms (for example, shortness of breath, nausea and vomiting, influenza-like symptoms, diarrhoea, lack of appetite, taste disturbances, dizziness, weight loss, trouble in v ision) and a better overall QoL until month 9. Thereafter, emotional, cognitive and social functioning and overall QoL deteriorated and pati ents reported more symptoms. Major complaints at baseline and follow-u p were associated with fatigue and emotional functioning: patients rep orted a strong need to rest, and felt very tired, worried, tense and i rritable. Conclusions: These results show that both treatments may hav e a temporary beneficial effect on patient QoL. QoL research may contr ibute to evaluation of clinical trials and provide patients with infor mation about the effects of treatment on their QoL, thus enabling them to make informed decisions.