UK-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
Conditions
Interventions
Trade Name: Celsentri
Product Name: UK-427,857
Product Code: UK-427,857
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mar
Sponsors
ViiV Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the antiviral activity (ie, fewer than 400/50 HIV 1 RNA copies per mL of plasma at Week 48), of each of two doses of UK 427,857 in combination with zidovudine/lamivudine is non inferior to a reference regimen of efavirenz plus zidovudine/lamivudine in antiretroviral naïve, CCR5-tropic HIV 1 infected subjects.; Secondary Objective: To assess whether the antiviral activity (fewer of 400/50 HIV-1 RNA copies/mL of plasma at week 24 and 96) in each of the 2 doses of UK427,857 in combination with zidovudine/lamivudine is non-inferior to a reference regimen of efavirenz plus zidovudine/lamivudine in antiretroviral-naïve, CCR5-tropic HIV-1 infected subjects. To compare the time to loss of virological response through week 48 and 96. To compare the reduction of plasma log10 HIV-1 RNA form baseline through weeks 24, 48 and 96. To compare the differences in the magnitude of changes in the CD4 and CD8 cell counts from baseline through week 24, 48 and 96. To compare the Time Average Difference in log10 HIV-1 RNA at week 24, 48 and 96. To assess HIV-1 genotype, phenotype and tropism at baseline and at the time of failure, and the association between baseline resistance and virological response. To assess the safety and the tolerability of the 2 UK-427,857 regimens versus placebo regimen. ;Primary end point(s): The percentage of patients with fewer than 400 copies and the percentage of patients with fewer than 50 copies of HIV-1 RNA per milliter of plasma at 48 weeks. | — |
Countries
Italy, Spain, United Kingdom
Contacts
Public ContactJonathan Gooch
Pfizer Limited
Outcome results
None listed