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
- 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: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2004-001914-15-GB
- Lead Sponsor
- ViiV Healthcare UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 891
Men or women at least 16 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? 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method