A multicentre, randomised, double-blind, comparative trial of a novel CCR5 antagonist, UK427,857, in combination with zidovudine/lamivudine versus efavirenz in combination with zidovudine/lamivudine for the treatment of antiretroviral-naïve HIV-1 infected subjects.

Pfizer S.A0 个研究点目标入组 1,071 人开始时间: 2005年5月26日最近更新: 2021年10月8日

适应症

试验速览

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•Men or women at least 18 years of age available of a follow up of at least 48 weeks.
•HIV-1 RNA viral load equal to or more than 2,000 copies of HIV-1 RNA per mL measured by Roche Amplicor HIV-1 Monitor at the screening visit.
•A negative urine pregnancy test at the baseline visit, prior to receiving the first dose of study medication for women of child bearing potential.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Suspected or document active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy (eg, hepatitis C virus infection) at the time of randomisation.
•Treatment for an active opportunistic infection or unexplained temperature superior to 38.5°C for 7 consecutive days, within 30 days prior to randomisation.
•HIV resistant to efavirenz, zidovudine or lamivudine.
•Prior treatment with any antiretroviral therapy for more than 14 days.
•Contraindicated medications being taken by the subject at the time of randomisation that must be continued during the study period, including immunomodulators (for the treatment of HIV-1 infection; interferon for the ongoing treatment of Hepatitis C infection is permitted), ketoconazole, itraconazole, miconazole, clotrimazole, troleandomycin, nefazadone, clarithromycin, rifampin and rifabutin.
•X4- or dual/mixed- topic virus detected by the PhenoSense viral entry assay or repeated assay failure.
•Primary HIV-1 infection.
•Renal insufficiency, increased bilirubin/AST/ALT, cytopenia.
•High risk of CAD/CVD.

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