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Titolo:
COMBINATION THERAPY WITH RECOMBINANT HUMAN SOLUBLE CD4-IMMUNOGLOBULIN-G AND ZIDOVUDINE IN PATIENTS WITH HIV-INFECTION - A PHASE-I STUDY
Autore:
MENG TC; FISCHL MA; CHEESEMAN SH; SPECTOR SA; RESNICK L; BOOTA A; PETRAKIS T; WRIGHT B; RICHMAN DD;
Indirizzi:
UNIV CALIF SAN DIEGO,DEPT MED,DIV INFECT DIS,200 W ARBOR DR SAN DIEGOCA 92103 UNIV MIAMI,SCH MED MIAMI FL 00000 UNIV MASSACHUSETTS WORCESTER MA 01605 GENENTECH INC S SAN FRANCISCO CA 94080
Titolo Testata:
Journal of acquired immune deficiency syndromes and human retrovirology
fascicolo: 2, volume: 8, anno: 1995,
pagine: 152 - 160
SICI:
1077-9450(1995)8:2<152:CTWRHS>2.0.ZU;2-W
Fonte:
ISI
Lingua:
ENG
Soggetto:
HUMAN-IMMUNODEFICIENCY-VIRUS; AIDS-RELATED COMPLEX; ENVELOPE GLYCOPROTEIN GP120; PLACEBO-CONTROLLED TRIAL; REDUCED SENSITIVITY; AZIDOTHYMIDINE AZT; DOUBLE-BLIND; CELL-FUSION; CD4; TYPE-1;
Keywords:
ZIDOVUDINE; RECOMBINANT SOLUBLE CD4 IMMUNOGLOBULIN G; COMBINATION THERAPY; PHARMACOKINETICS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
36
Recensione:
Indirizzi per estratti:
Citazione:
T.C. Meng et al., "COMBINATION THERAPY WITH RECOMBINANT HUMAN SOLUBLE CD4-IMMUNOGLOBULIN-G AND ZIDOVUDINE IN PATIENTS WITH HIV-INFECTION - A PHASE-I STUDY", Journal of acquired immune deficiency syndromes and human retrovirology, 8(2), 1995, pp. 152-160

Abstract

To determine the effect of zidovudine (ZDV) on the pharmacokinetic disposition of recombinant soluble CD4 immunoglobulin G (rCD4-IgG) and to evaluate the safety and preliminary activity of concurrent administration of ZDV with rCD4-IgG, we undertook an open-label, dose-escalating, 12-week study. The regimens of intravenous rCD4-IgG and oral ZDV weused were (a) 300 mu g/kg rCD4-IgG twice per week and 300 mg ZDV per day, (b) 300 mu g/kg rCD4-IgG twice per week and 600 mg ZDV per day, (c) 1,000 mu g/kg rCD4-IgG twice per week and 300 mg ZDV per day, (d) 1,000 mu g/kg rCD4-IgG twice per week and 600 mg ZDV per day, and (e) 3,000 mu g/kg rCD4-IgG twice per week and 300 mg ZDV per day. Subjects were recruited from three AIDS clinical trials units. Forty-one patients with HIV infection who had CD4 cell counts less than or equal to 500 cells/mm(3) and <120 days of previous ZDV therapy participated. Pharmacokinetic interactions were assessed with the second regimen. Mean calculated peak serum rCD4-IgG concentrations were 5.47 mu g/ml with ZDV and 8.28 mu g/ml without ZDV, with serum half-lives of 34.2 and 32.0h, respectively. Antibodies to rCD4-IgG were not detected. Seven episodes of severe adverse events occurred in five patients: one episode each of severe nausea, fever, pr abnormal liver function tests and fourepisodes of severe neutropenia. Mean hemoglobin and neutrophil countsdecreased, and mean platelet counts increased in all regimens, but there were no significant differences among regimens, rCD4-IgG dose, or ZDV dose. Mean CD4 cell counts rose with all regimens except the first, and mean serum p24 antigen declined with all regimens; however, there were no significant differences in CD4 cell count or serum p24 antigen response among regimens, ZDV doses, rCD4-IgG doses, or by previous ZDV therapy. CD4 lymphocyte elevations were neither greater nor more sustained than has been observed with ZDV alone. Combining ZDV with rCD4-IgG was well tolerated and did not appear to affect the pharmacokinetic disposition of rCD4-IgG. The response of surrogate markers did notappear to improve over that observed with ZDV alone.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/12/20 alle ore 15:49:19