A multicentre, randomised, double-blind, placebo-controlled trial of novel CCR5 antagonist, UK-427,857, in comination with optimised background therapy versus optimised background therapy alone for the treatment of antiretroviral-experienced, non CCR5-tropic and HIV-1 infected subjects

• Conditions: K-427,857 is an antagonist of the human chemokine receptor, and is intended to help prevent the development and progression of AIDS in individuals HIV-1 positive.

• Registration Number: EUCTR2004-001779-20-DE
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-28
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

HIV-1 RNA superior to or equal to 5000 copies/mL measured by Roche Amplicor HIV-1 monitor at screening visit.
Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks.
Treatment experience criteria as defined in the protocol.
A negative urine pregnancy test at the baseline visit prior to receiving the first dose of study medication for women child bearing protential.
Are the trial subjects under 18? yes
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

Exclusion Criteria

Patient requiring treatment with more than 6 antiretroviral agents (excluded low dose ritonavir).
Prior treatment with UK-427,857 or another experimental HIV entry inhibitor for more than 14 days.
Suspected or documented active, untreated HIV-1related opportunistic infection (OI) or other conditions requiring acute therapy (eg Hepatitis C virus infection) at the time of randomisation.
R5 virus phenotype only, as determined by PhenoSense viral entry assay.
Renal insufficiency, increased bilirubin/AST/ALT, cytopenia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified