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M94A2847.TXT
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1994-10-25
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Document 2847
DOCN M94A2847
TI A phase I/II open label combination study of the tolerability and
activity of ddC and interferon alpha in patients with early symptomatic
HIV-infection (ANRS protocol 016).
DT 9412
AU Mouton Y; Goujard C; Raffi F; Seigneurin JM; Bilbault P; ANRS, Paris,
France.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):211 (abstract no. PB0274). Unique
Identifier : AIDSLINE ICA10/94369728
AB OBJECTIVES: Tolerability and antiviral activity of dideoxycytidine alone
or in combination with two doses of interferon alpha based on laboratory
markers (CD4, Ag P24, 82 microglobulin). To investigate the usefulness
of quantitative plasma and cellular viraemia and quantitative RNA and
DNA PCR. METHODS: In this open label multicenter phase I/II study 60
HIV-infected patients with CD4 < or = 500 > or = 200 were randomized to
receive ddC orally (0.75 mg twice daily) either alone or in combination
with s.c. interferon alpha 2 A (1 M or 9 M thrice weekly) for 16 weeks.
Patients had not previously received antiviral therapy but were at risk
of disease progression (positive Ag P24 at baseline). RESULTS: 59
patients were evaluated in 11 centers: 18 (ddC arm). 41 (ddC.IFN alpha
combination arms). 21 patients received the low dose and 20 the high
dose of IFN alpha. There were no differences in CDC classification
between the two groups at baseline. However the CD4 cell count and Ag
P24 titer showed more advanced disease in the ddC arm: median CD4 256
cells/mm3 and median Ag p24 288 pg/ml compared to median CD4 346
cells/mm3 and median Ag P24 155 pg/ml for the combination groups.
Preliminary results over 16 weeks of treatment have not shown difference
between the groups regarding the absolute change or % change from
baseline for the CD4 count and for the change from baseline for the Ag
P24 and the beta microglobulin but a 50 cells increase in ddC mono arm
at week 4 was observed (see table below) and both groups showed
substantial decline in P24. TABULAR DATA, SEE ABSTRACT VOLUME. Treatment
was well tolerated for both monotherapy and combination (7 early
discontinuations were observed). Preliminary data on the viral load on
51 patients indicate an overall response showing clear antiviral
activity. The complete results by therapy arm will be presented as well
as results of susceptibility testing on viral isolates. CONCLUSIONS: The
effects on the laboratory markers are difficult to interpret because of
differences of baselines for the treatment groups even though the
randomisation was respected. However this open label trial was also
designed to further investigate quantitative viraemia and PCR the full
analysis of which has been completed on most of the patients.
DE beta 2-Microglobulin/ANALYSIS Biological Response
Modifiers/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE
Combined Modality Therapy Comparative Study Human HIV Core Protein
p24/BLOOD HIV Infections/DRUG THERAPY/*THERAPY Interferon
Alfa-2a/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE
Leukocyte Count Treatment Outcome T4 Lymphocytes Viremia/DRUG
THERAPY/THERAPY Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE
EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL CLINICAL TRIAL, PHASE I
CLINICAL TRIAL, PHASE II MEETING ABSTRACT MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).