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M94A2879.TXT
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1994-10-25
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Document 2879
DOCN M94A2879
TI Phase I/II study of curdlan sulfate--an HIV inhibitor.
DT 9412
AU Gordon M; Guralnik M; Lang W; Baker M; Goodgame J; DeMarzo C; Mimura T;
Kaneko Y; AJI PHARMA USA, Inc., Glenpointe Centre West, Teaneck, NJ
07666.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no. PB0244). Unique
Identifier : AIDSLINE ICA10/94369696
AB OBJECTIVE: To assess the safety, tolerance and pharmacokinetics of
curdlan sulfate (CRDS), a semisynthetic beta-glucan, in HIV-positive
individuals who have CD4 T-lymphocytes below 500 cells/cmm, administered
as single doses over 30 minutes, or four hours, or daily for seven days.
METHODS: CRDS was administered in separate studies to (1) three patients
each at doses of 1, 10, 30, 100, 200 and 300 mg/70 kg infused over a 4
hour period (2) two or three patients each at doses of 25, 50, 75, 100,
125, 150, 175 and 200 mg/70 kg infused over 30 minutes (3) 3 patients
each at doses of 40, 100, 140 and 180 mg/70 kg daily for 4 hours for 7
days iv. Parameters measured were activated partial thromboplastin time
(APTT), CD4, p24 antigen, chemistry and T-cell panels. RESULTS: CRDS has
been found to be well tolerated at all doses. There were no clinical
side effects or adverse changes in laboratory parameters other than the
expected increase in APTT at higher doses, which reverted promptly to
normal. Elevations in p24 antigen or drops in thrombocytes, previously
seen with dextran sulfate, were not observed. At higher doses of CRDS
marked unexpected increases in CD4 levels were observed which remained
elevated for 4-24 hours. The half-life of CRDS was found to be 2-3
hours. CONCLUSIONS: CRDS was well tolerated at all doses. If the marked
increases in CD4 levels can be confirmed they may have therapeutic
significance. Combination trials are recommended in HIV and in CMV
disease.
DE Antiviral Agents/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE
Glucans/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE Half-Life
Human Safety Treatment Outcome CLINICAL TRIAL CLINICAL TRIAL, PHASE
I CLINICAL TRIAL, PHASE II MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).