Zidovudine in patients with human immunodeficiency virus (HIV) infection and Kaposi sarcoma. A phase II randomized, placebo-controlled trial.
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.


METHODS
Randomized, double-blind, placebo-controlled trial.


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


METHODS
Physician-referred volunteer patients with HIV infection, Kaposi sarcoma, CD4+ lymphocyte counts greater than 0.2 x 10(9)/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.


METHODS
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.


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.
Lane
H C
HC
National Institutes of Health, Bethesda, Maryland.
Falloon
J
J
Walker
R E
RE
Deyton
L
L
Kovacs
J A
JA
Masur
H
H
Banks
S
S
Kirk
L E
LE
Baseler
M W
MW
Salzman
N P
NP
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D000328:Adult; D000740:Anemia / Q000139:chemically induced; D004311:Double-Blind Method; D004341:Drug Evaluation; D006098:Granulocytes / Q000187:drug effects; D006678:HIV / Q000187:drug effects; D006801:Humans; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000209:etiology; D015215:Zidovudine / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
D015215:Zidovudine