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Zidovudine in Patients with Human Immunodeficiency Virus (HIV) Infection and Kaposi Sarcoma: A Phase II Randomized, Placebo-Controlled Trial

H. Clifford Lane, MD; Judith Falloon, MD; Robert E. Walker, MD; Lawrence Deyton, MD; Joseph A. Kovacs, MD; Henry Masur, MD; Steven Banks, PhD; L. Edward Kirk, MS; Michael W. Baseler, PhD; Norman P. Salzman, PhD; and Anthony S. Fauci, MD
[+] Article, Author, and Disclosure Information

Grant Support: Supported in part with Federal funds from the Department of Health and Human Services under contract number NO1-CO-74102.

Requests for Reprints: H. Clifford Lane, MD, Laboratory of Immunoregulation, NIAID, National Institutes of Health, Building 10, Room 11B13, Bethesda, MD 20892.

Current Author Addresses: Drs. Lane and Fauci: Laboratory of Immunoregulation, NIAID, National Institutes of Health, Building 10, Room 11B13, Bethesda, MD 20892.

Drs. Falloon, Kovacs, and Masur: Critical Care Division, National Institutes of Health, Building 10, Room 10D48, Bethesda, MD 20892.

Dr. Walker: Cardiovascular-Pulmonary Division, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104.

Dr. Deyton: 6003 Executive Boulevard, Room 247 P, National Institutes of Health, NIAID, AIDS Program, Rockville, MD 20852.

Dr. Banks: Office of the Scientific Director, NIAID, National Institutes of Health, Building 10, Room 11N238, Bethesda, MD 20892.

Mr. Kirk: Burroughs-Wellcome Company, 3030 Cornwallis Road, Research Triangle Park, NC 27709.

Dr. Baseler: Frederick Cancer Research Facility, NCI Program Resources, Inc., P.O. Box B, Frederick, MD 21701.

Dr. Salzman: Room LM12 Preclinical Building, Georgetown University, Washington, DC 20007.

Ann Intern Med. 1989;111(1):41-50. doi:10.7326/0003-4819-111-1-41
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Study Objective: To evaluate the toxicity, effects on immune function, antitumor effects, antiretroviral effects, and pharmacokinetics of zidovudine therapy in patients with early human immunodeficiency virus (HIV) infection and Kaposi sarcoma.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: National Institutes of Health, a referral-based research institution (single site).

Patients: Physician-referred volunteer patients with HIV infection, Kaposi sarcoma, CD4+ lymphocyte counts greater than 0.2 X 109/L, and no systemic symptoms or history of opportunistic infection. Of 41 patients enrolled, 4 had not met all entry criteria and were therefore not evaluable.

Interventions: Patients were randomized to one of four treatment groups for an initial 12-week treatment period: oral placebo (9 patients); zidovudine, 250 mg orally every 4 hours (9 patients); zidovudine, 0.5 mg/kg body weight intravenously every 4 hours (9 patients); and zidovudine, 2.5 mg/kg intravenously every 4 hours (10 patients). After at least 12 weeks of therapy at their assigned dose, patients were treated with oral zidovudine, generally 250 mg every 4 hours, with a mean 42-week follow-up.

Measurements and Main Results: Anemia and granulocytopenia were the major toxicities. Significant increases in platelet counts and declines in serum HIV antigen and IgG and IgM levels occurred in treated patients. Treated patients were more likely than those on placebo to clear HIV from the cerebrospinal fluid. There were no differences in tumor progression or CD4+ or CD8+ lymphocyte counts among the groups.

Conclusions: Zidovudine was well tolerated and had antiretroviral activity in patients with early HIV infection and Kaposi sarcoma but it had no significant effect on the extent of Kaposi sarcoma or on immune function.





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