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.
Conditions
Interventions
Product Name: UK-427,857
Product Code: UK-427,857
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Maraviroc
CAS Number: 376348-65-1
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
PFIZER LTD
Eligibility
Sex/Gender
All
Inclusion criteria
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 two fo 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
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, cytopenia. High risk for CAD/CVD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the hypothesis that UK-247,857 added to Optimised Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone, as measured by the difference between each of the two UK-427,857 regimens versus the placebo regimen in the mean changes from baseline in plasma HIV-1 RNA at week 48. An interim analysis will be performed at week 24.;Secondary Objective: To compare the percentage of subjects with HIV-RNA less than 400 copies/mL and 5O copies/mL at week 24 and 48. To compare the percentage of subjects who achieve at least a 0.5 log10 and 1log10 reduction in HIV-RNA from baseline at week 24 and 48. To compare the time to loss of virological response through week 48. To compare the differences in the magnitude of changes in the CD4 and CD8 cell counts from baseline through week 24 and 48. To compare the Time Average Difference in log10 HIV-1 RNA at week 24 and 48. 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): Change from baseline to 48 weeks in HIV-1 RNA measured on a logarithmic (base 10) scale. An interim analysis will be performed at week 24. | — |
Countries
Germany, Italy, Spain, Sweden
Outcome results
None listed