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

Phase 1

• 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 indivuduals HIV-1 positive.; MedDRA version: 9.1 Level: LLT Classification code 10020180 Term: HIV positive

• Registration Number: EUCTR2004-001778-21-GB
• Lead Sponsor: Pfizer Limited, Ramsgate Road, Sandwich, KENT. CT13 9NJ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-31
• Study Completion: 2011-04-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

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.
Documented genotypic or phenotypic resistance to 3 of 4 antiretroviral drug classes.
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.
X4- or dual/mixed-tropic virus detected by PhenoSense viral entry assay or repeated assay failure.
Renal insuffiecency, increased bilirubin/AST/ALT.

Study & Design

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