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1996-03-09
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Document 0226
DOCN M9650226
TI Hydroxychloroquine treatment of patients with human immunodeficiency
virus type 1.
DT 9605
AU Sperber K; Louie M; Kraus T; Proner J; Sapira E; Lin S; Stecher V; Mayer
L; Division of Clinical Immunology, Mount Sinai Medical Center, New;
York, New York, USA.
SO Clin Ther. 1995 Jul-Aug;17(4):622-36. Unique Identifier : AIDSLINE
MED/96098329
AB Hydroxychloroquine (HCQ), an antimalarial agent used to treat patients
with autoimmune diseases, has been shown to suppress human
immunodeficiency virus type 1 (HIV-1) replication in vitro in T cells
and monocytes by inhibiting posttranscriptional modification of the
virus. These in vitro observations have been expanded into an in vivo
study of HCQ as a potential anti-HIV-1 agent in HIV-1-infected patients.
A randomized, double-blind, placebo-controlled clinical trial was
conducted in 40 asymptomatic HIV-1-infected patients who had CD4+ counts
between 200 and 500 cells/mm3. Patients were randomly assigned to
receive either HCQ 800 mg/d or placebo for 8 weeks. Virologic and
immunologic parameters, including HIV-1 ribonucleic acid (RNA) via use
of polymerase chain reaction, viral culture, antigen and mitogen
responses, and proinflammatory cytokine levels were measured at the
beginning and end of the study. The amount of recoverable HIV-1 RNA in
plasma declined significantly in the HCQ group over the 8-week period (P
= 0.022), while it increased in the placebo group. The percentage of
CD4+ T cells remained stable in the HCQ-treated group (18.1 +/- 9.2%
before treatment vs 18.6 +/- 10.5% after treatment) and fell
significantly in the placebo group (21 +/- 7% before treatment vs 19.3
+/- 6.3% after treatment; P = 0.032). However, this was not reflected as
a change in absolute CD4+ counts for either group (HCQ, 262.8 +/- 166
cells/mm3 vs 251 +/- 163 cells/mm3; placebo, 312 +/- 121 cells/mm3 vs
321 +/- 124 cells/mm3). Mitogen- and antigen-specific responses remained
constant in the HCQ group while T cell proliferative responses to
Candida decreased in the placebo group (4.8 +/- 3.6 x 10(3) SI
[stimulation index] vs 3.0 +/- 3.0 x 10(3) SI; P = 0.032). Lastly, serum
interleukin 6 levels declined in the HCQ group (14.3 +/- 13.5 U/mL vs
12.0 +/- 16.7 U/mL; P = 0.023) but not in the placebo group (11.3 +/-
8.8 U/mL vs 7.0 +/- 11.7 U/mL); this was coincident with a decrease in
serum immunoglobulin (Ig)G (2563 +/- 1352 mg/mL vs 2307 +/- 1372 mg/dL;
P = 0.032), compared with the placebo group (2733 +/- 1473 mg/dL vs 2709
+/- 1501 mg/dL). No other parameters, including serum p24 and beta-2
microglobulin levels, were altered by HCQ therapy. HCQ thus may be
useful in the treatment of patients with HIV-1 infection.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/IMMUNOLOGY/ VIROLOGY
Adult Antiviral Agents/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC
USE Base Sequence CD4-Positive T-Lymphocytes/DRUG EFFECTS
Double-Blind Method Female Human Hydroxychloroquine/ADVERSE
EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE *HIV-1/DRUG
EFFECTS/PHYSIOLOGY Interleukin-6/METABOLISM Lymphocyte Count/DRUG
EFFECTS Male Middle Age Molecular Sequence Data RNA Probes RNA,
Viral/ANALYSIS Support, U.S. Gov't, P.H.S. Virus Replication/DRUG
EFFECTS CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).