AEGiS-11IAC: "Soft" and "hard" measures of energy/fatigue in HIV trials.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

"Soft" and "hard" measures of energy/fatigue in HIV trials.

Int Conf AIDS 1996 Jul 7-12; 11:231 (abstract no. Tu.B.174)
Doob PR, Johnson KM, St Cyr J, MacFadden DK; York University, North York, ON, Canada. Fax: 416-465-2695. E-mail: prdoob@YorkU.Ca.

OBJECTIVE: To examine potential "hard" endpoints for change in HIV-related fatigue and their relation to "soft" health-related quality of life (HRQL) measures.

METHODS: 15 HIV+ patients with severe fatigue and CD4 counts less than 200 were enrolled in an exploratory open label study of Peptide T (8.5mg/d s.c.). Tests included the 6-Minute Walk Test (6MWT) and Borg Perceived Exertion Scale (0, 3, 6 wks), grip strength and neuropsychological tests (0, 6 wks), and HRQL measures (MOS-HIV, Psychological General Well-Being [PGWB], Beck Depression Inventory [BDI], and a symptom severity checklist [SSC]) at wks 0, 3, 6, 9, 12, 15. Electronic personal activity monitors (PAMs) were worn for 1 wk pre-baseline and at wks 3 and 6.

RESULTS: Objective measures: Patients improved on the 6MWT (paired T test, mean 52.6m, p=0.02, at wk 3 and 56.9m, p=0.0004, at wk 6) while Borg perceived exertion declined (-1.6, p=0.009, wk 3; -2.4, p=.0006, wk 6). Grip strength improved (p=.005 dom, p=.1 non-dom), as did other NP tests including FAS/CFL verbal fluency and finger-tapping (dom). Results from PAMs, used for the first time in HIV trials, were inconclusive, with collection and analysis of PAM data problematic. HRQL measures: MOS-HIV Energy-Fatigue and PGWB Vitality subscales showed significant improvement (greater than 2 baseline s.d. for the MOS-HIV, p ranging from.0002 to.013), as did SSC items fatigue and weakness and a MOS summary score. Measures of depression generally did not show significant improvement. Correlation analyses between and within types of tests indicated high inter-correlation of change in HRQL but at best (Fatigue) a correlation of only.4708 (Pearson; p=.089) with the 6MWT. In the NP group, FAS/CFL was correlated with SSC Fatigue and Weakness (r=.6675 and.5950, p=.02 and.05), while finger tapping (dom) showed a trend towards correlation with the Walk Test (.5873, p=0.07).

CONCLUSIONS: Identifying appropriate "hard" measures of change in HIV-related fatigue remains problematic. While many measures indicated substantial improvement, correlations between "soft" and "hard" measures were weak, perhaps because HRQL measures demand a 4 wk retroactive assessment while "hard" measures are taken on a single day. The PAM, difficult to use and analyze, may not be well suited to HIV trials.

Keywords: AEGIS, Fatigue, CD4 Lymphocyte Count, HIV Infections, Anti-HIV Agents, Weights and Measures, Exertion, Outcome Assessment (Health Care), Paresis, Peptide T, District of Columbia, Human, chemistry, ICA11

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