Functional status and well-being in a placebo-controlled trial of zidovudine in early ARC.

Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.

Functional status and well-being in a placebo-controlled trial of zidovudine in early ARC.

Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no. Th.B.19). Unique Identifier : AIDSLINE ICA6/10001990
Wu AW; Rubin HR; Mathews WC; Brysk LM; Hardy WD; Bozzette SA; Atkinson JH; Grant I; Richman DR; University of California, San Francisco, CA, USA

Abstract: OBJECTIVE: To examine the impact of zidovudine (ZDV) on functional status and well-being in persons with early ARC. METHODS: Seventy-one subjects were randomized to ZDV 200 mg (n = 35) or placebo (n = 36) as part of ACTG Protocol 016. We measured health status at baseline, 1 month, and every 3 months thereafter. Our instruments were the newly developed MOS-HIV Health Survey, (subscales scored 0-100), and the Quality of Well-being Scale (QWB). Mean time on-study was 53 weeks (S.D. = 26). Treatment effects were calculated using paired and unpaired t-tests. RESULTS: While there was evidence that ZDV initially reduced health and well-being, this effect did not persist. Using the MOS-HIV Health Survey, at 24 weeks scores on most subscales had improved for the placebo group, while some had declined for the ZDV group; the groups had significantly different changes from baseline in energy (placebo, + 10 vs. ZDV, -1; p = .002) and overall health (placebo, +5 vs. ZDV, -6.5; p = .05). At this point, both ZDV and placebo groups had improved mental health and less health distress than at enrollment (paired t-test, p less than .0005). Thereafter, subjects on ZDV declined less than those on placebo; at 52 weeks both groups' scores were similar to baseline on all subscales. Using the QWB, there were no significant differences over time in either group. CONCLUSION: Our study showed that while ZDV caused little morbidity, it also did not dramatically improve functional status and well-being of those with early ARC. We suggest that future studies include health status instruments as outcome measures, as well as mortality and progression of disease.

Keywords: AIDS-Related Complex/*DRUG THERAPY Human *Quality of Life Randomized Controlled Trials Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL
901230
M90C3699

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, Gill Foundation, the National Library of Medicine, Quest Diagnostics, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 1990. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1990. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .