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1994-10-25
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Document 2881
DOCN M94A2881
TI Phase I/II trial of oral Panavir for HIV infection.
DT 9412
AU Nagourney RA; Hendler SS; Sanchez RA; Strayer G; Sonne M; Lauermann MW;
Long Beach Memorial Medical Center, CA 90801-1428.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):203 (abstract no. PB0239). Unique
Identifier : AIDSLINE ICA10/94369694
AB OBJECTIVE: To determine safety, efficacy and bioavailability of Panavir
(4,4'-isopropylidenedithio-bis-2,6-di-t-butylphenol, specially
formulated) as an oral HIV drug. METHODS: From July 1992 to February
1994, 25 HIV+ adults received daily oral Panavir at 200 mg (n = 6), 400
mg (n = 7) and 800 mg (n = 12). Age range 27-66; 22 male/3 female; CD4 <
10 to 500; Karnofsky scores 70-100; prior antiretroviral therapy in
16/25; no other antiretroviral therapy given while on study. Endpoints
were a) Clinical: CD4, opportunistic infections (OI), AIDS-related
malignancy (ARM), HIV p24 Ag, weight, Karnofsky score, and Quality of
Life (QOL); b) Safety/tolerance: cardiac, renal, hepatic, hematologic &
GI; and c) Bioavailability: steady state drug level (SS) and time to SS.
RESULTS: Of 25 patients, the initial 19 accrued during 7/92-4/93 with
median CD4 = 77 [6 of 19 had CD4 < 10]. The trial was revised on 7/93 to
300 < CD4 > 500 (final 6 accruals). There were no cardiac, renal or
hepatic toxicities. Mild GI toxicities (flatulence, diarrhea) were seen.
There were no drug related deaths or serious toxicities. With increasing
dosage, there appeared to be a trend toward stabilization or slight
elevations of CD4. Karnofsky score, weight and QOL remained stable or
declined slowly in the first 19 patients but remained stable in the last
6. HIV p24 Ag and beta-2-microglobulin varied. While 3 patients
developed OI, none developed ARM. Dose (SS): 200 mg (12 ug/ml), 400 mg
(18 ug/ml); 800 mg (26 ug/ml). Time to steady state was 2-3 weeks in
each case. There was evidence for significant activity against painful
peripheral neuropathy and against Molluscum contagiosum. DISCUSSION AND
CONCLUSIONS: Panavir is a well tolerated novel agent for the treatment
of HIV infection with a unique mode of action related to antioxidant,
anti-HIV, and possibly anti-apoptotic properties.
DE Administration, Oral Adult Aged Antioxidants/ADMINISTRATION &
DOSAGE/ADVERSE EFFECTS/ PHARMACOKINETICS/THERAPEUTIC USE Antiviral
Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
PHARMACOKINETICS/*THERAPEUTIC USE Biological Availability Female
Gastrointestinal Diseases/CHEMICALLY INDUCED Human HIV
Infections/*DRUG THERAPY Male Middle Age Probucol/ADMINISTRATION &
DOSAGE/ADVERSE EFFECTS/PHARMACOKINETICS/ *THERAPEUTIC USE 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).