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A Randomized Controlled Trial

Samuel A. Bozzette, MD; David E. Kanouse, PhD; Sandra Berry, MA; Naihua Duan, PhD; R; David J. Gocke, MD; Steven I. Marlowe, MD, FACP; John C. Pottage, Jr, MD; Stephen E. Follansbee, MD; Scot Remick, MD; Nancy Klimas, MD; Peter Jensen, MD; David H. Henry, MD; Richard Olson, DO; Paul A. Turner, MD; Jacob P. Lalezari, MD; John Phair, MD; Richard Pollard, MD; Phillip F. Pierce, MD; Louis D. Saravolatz, MD; Stuart Cohen, MD; Thomas Cate, MD; P. Samuel Pegram, MD; Jared Spotkov, MD; John T. Carey, MD; George Perez, MD; Carla Pettinelli; Theo DownesLeGuin; Donna Hill; Carol Edwards; Rebecca Mazel; Ronald Hays; Anita Stewart; Whaijen Soo, MD, PhD; Miklos Salgo, MD, PhD; Marvin Anthony; Dennis Dixon, PhD; Maureen Myers, PhD.

JAMA. 1995;273(4):295-301.

Abstract
Objective.
—To evaluate the functional and health status implications of prescribing zalcitabine or zidovudine for initial therapy of acquired immunodeficiency syndrome (AIDS).

Design.
—A substudy of a randomized controlled trial.

Setting.
—Private and public clinics and referral centers.

Patients.
—Had human immunodeficiency virus (HIV) infection, less than 0.20x10⁹/L (200 µL) CD4⁺ cells, and either a history of Pneumocystis carinii pneumonia or symptoms of HIV infection. Fifty-eight percent (338/668) of main study enrollees representing 90% of enrollees at participating sites were included in this substudy.

Interventions.
—Either zalcitabine at 0.75 mg every 8 hours plus inactive capsules identical in appearance to zidovudine or zidovudine at 200 mg (later 100 mg) every 4 hours plus inactive tablets identical in appearance to zalcitabine.

Main Outcome Measures.
—Results of a periodically completed self-report survey instrument containing specific questions about symptom impact, disability, work, functioning, and utilization as well as nine health and functioning scales adapted from the Medical Outcomes Study (MOS).

Results.
—Zalcitabine recipients were twice as likely to undergo an invasive procedure (P=.004) or be admitted to hospital (P=.01). Zalcitabine recipients reported greater than 40% more symptoms that interfered with activity (P=.001) and greater than 50% more disability days (P<.01). They also had a 7% lower employment rate and a 35% lower monthly income. Average observed health status scores were lower in zalcitabine recipients overall, but especially in the early portion of the study. New methods for combining survival and health status data showed that, over 76 weeks of study, a typical zidovudine recipient spent about 4(10%) more weeks with at least the typical health state than did a typical zalcitabine recipient.

Conclusions.
—Zidovudine has substantial advantages over zalcitabine in initial monotherapy of AIDS in terms of functional outcomes such as symptom impact, disability, work, utilization, and health status. In this case, the differences in functional outcomes presaged differences in physiological and clinical measures. The inclusion of functional outcomes can greatly improve the information available from a clinical trial.

(JAMA. 1995;273:295-301)

Author Affiliations
for the Roche 3300/ACTG 114 Study Group; obert Wood Johnson Medical School, New Brunswick, NJ; AIDS Research Consortium of Atlanta (Ga); RushPresbyterian-St Luke's Medical Center, Chicago, Ill; Davies Medical Center, San Francisco, Calif; Albany (NY) Medical Center; Miami (Fla) Veterans Administration Medical Center; Veterans Administration Medical Center, San Francisco, Calif; The Graduate Hospital, Philadelphia, Pa; Oak Lawn Physician's Group, Dallas, Tex; Kaiser Permanente Sunset, Los Angeles, Calif; Mount Zion Medical Center of the University of California, San Francisco; Northwestern University Medical School, Chicago, Ill; University of Texas Medical Branch, Galveston; Georgetown University; Hospital, Washington, DC; Henry Ford Hospital, Detroit, Mich; University of California, Davis; Baylor College of Medicine, Houston, Tex; The Bowman Gray School of Medicine, Winston-Salem, NC; Kaiser Foundation Hospital, Harbor City, Calif; University Hospitals of Cleveland (Ohio); St Michael's Medical Center, Newark, NJ; ACTG Program Office, Bethesda, Md; RAND, Santa Monica, Calif; This study was supported by RAND, the AIDS

From the Health Sciences Program, RAND, Santa Monica, Calif (Drs Bozzette, Kanouse, and Duan and Ms Berry), and the Department of Medicine, University of California, San Diego, School of Medicine and the San Diego Veterans Affairs Medical Center, La Jolla, Calif (Dr Bozzette). Dr Bozzette is an HSR&D Senior Research Fellow of the Department of Veterans Affairs.

Footnotes
A complete list of the Roche 3300/ACTG Study Group appears at the end of this article.

Corresponding author: Samuel A. Bozzette, MD, RAND, 1700 Main St, Santa Monica, CA 90407-2138.

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