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Jacobson, Jeffrey M.; Saag, Michael S.; Thompson, Melanie A.; Fischl, Margaret A.; Liporace, Ralph; Reichman, Richard C.; Redfield, Robert R.; Fichtenbaum, Carl J.; Zingman, Barry S.; Patel, Mahesh C.; Murga, Jose D.; Pemrick, Suzanne M.; D'Ambrosio, Paul; Michael, Marti; Kroger, Hans; Ly, Hieu; Rotshteyn, Yakov; Buice, Robert; Morris, Stephen A.; Stavola, Joseph J.; Maddon, Paul J.; Kremer, Alton B.; Olson, William C.
The Journal of infectious diseases, 11/2008, Letnik: 198, Številka: 9Journal Article
Background. The current goal of human immunodeficiency virus type 1 (HIV-1) therapy is to maximally suppress viral replication. Securing this goal requires new drugs and treatment classes. The chemokine receptor CCR5 provides an entry portal for HIV-1, and PRO 140 is a humanized monoclonal antibody that binds to CCR5 and potently inhibits CCR5-tropic (R5) HIV-1 in vitro. Methods. A randomized, double-blind, placebo-controlled, dose-escalating study was conducted in 39 individuals with HIV-1 RNA levels ⩾5000 copies/mL, CD4+ cell counts ⩾250 cells/µL, no antiretroviral therapy for 3 months, and only R5 HIV-1 detectable. Cohorts were randomized 3:10 to receive placebo or doses of PRO 140 of 0.5, 2, or 5 mg/kg. Subjects were monitored for 58 days for safety, antiviral effects, and serum concentrations of PRO 140. Results. PRO 140 was generally well tolerated and demonstrated potent, rapid, prolonged, and dose-dependent antiviral activity. Mean reductions in HIV-1RNAlevel of 0.58 log10, 1.20 log10 (P = .0002) and 1.83 log10 (P < .0001) were observed for the 0.5-, 2-, and 5-mg/kg dose groups, respectively. Reductions in mean viral load of ⩾10-fold were observed within 4 days and persisted for 2–3 weeks after treatment. Conclusions. This trial established clear proof of concept for PRO 140 as a potent antiretroviral agent with extended activity after a single dose. Trial registration. ISRCTN Register: ISRCTN45537485.
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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