Incidence of AIDS dementia in a two-year follow-up of AIDS and ARC patients on an initial phase II AZT placebo-controlled study: San Diego cohort.

In a prospective study to determine the incidence of clinical dementia in patients with AIDS and ARC, 29 men and 3 women, 19 with ARC and 13 with AIDS, were examined neurologically and neuropsychologically every 6 months for 2 years during a placebo-controlled zidovudine (AZT) licensing trial. Most received two MRI brain scans. Although no patient was clinically demented at baseline, 9 (28%) developed dementia during the 2 years. Progression to dementia was associated with neuropsychological deterioration and with worsening on MRI during a preceding 6-month period, but not with baseline treatment group assignment. The results suggest that patients at CDC Stage IV who do not receive antiretroviral treatment earlier in their illness may develop clinical dementia at an annual rate of about 14%.

A health status questionnaire using 30 items from the Medical Outcomes Study. Preliminary validation in persons with early HIV infection.

Many current health status instruments either are too long to use in many acquired immune deficiency syndrome (AIDS) clinical trials or omit important concepts. In this study, human immunodeficiency virus (HIV)-relevant items developed for the Medical Outcomes Study (MOS) from subscales for cognitive function, energy/fatigue, health distress, and a single quality of life item were added to a portion of the MOS Short-form General Health Survey. The resulting 30-item questionnaire reliably and distinctly measured ten aspects of health and took less than 5 minutes to complete. To test its validity, this modified measure was used to compare the health of 73 subjects with asymptomatic HIV infection and 44 with early AIDS-related complex (ARC). Compared with ARC subjects, asymptomatic individuals reported superior overall health, less pain, and better physical function, role function, cognitive function, and quality of life (rank-sum, P less than 0.02). Asymptomatic subjects' scores were higher on most subscales than the age-adjusted scores of MOS outpatients with hypertension, diabetes, recent myocardial infarction, or depression; ARC patients scored closest to hypertensive patients. This instrument, containing a subset of the MOS measures of health-related quality of life, may be a useful outcome measure for AIDS clinical trials.

Quality of life in a placebo-controlled trial of zidovudine in patients with AIDS and AIDS-related complex.

We measured quality of life using the Karnofsky Performance Status and Quality of Well-Being scale (QWB) for 31 patients with AIDS and AIDS-related complex in a placebo-controlled trial of zidovudine. Sixteen patients were randomized to zidovudine and 15 to placebo. We recorded nine scores for each patient during 1 year. During the blinded trial, 3 patients receiving placebo died; at 1 year, one had died in the zidovudine group and 10 in the placebo group. Repeated-measures analysis of variance demonstrated that mean scores declined less for the zidovudine group than for the placebo group during the blinded trial (p less than 0.03) and during 1 year (p less than 0.002). However, because the QWB incorporates death into its score, these results largely reflected differences in mortality. When data from those who died were excluded, Karnofsky scores were higher for the zidovudine group at the end of the blinded trial (p less than 0.02), but at 1 year no significant differences were observed between groups. The QWB and other quality-of-life measures may contribute to more comprehensive evaluation of AIDS treatments, and may detect treatment effects earlier. Whether existing measures can detect real differences among survivors will require testing in patients with less advanced disease.