UK-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.
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/g milligram(s)/gram
Concentration typ
Sponsors
Pfizer Limited
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. 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
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. High risk for CAD/CVD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm that the hypothesis that UK-427,857 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 24.;Secondary Objective: To assess whether UK-427,857 added to OBT provides an additional reduction in plasma HIV-1 RNA compared to OBT alone, as measured by the difference between each of the 2 UK-427,857 regimens versus placebo regimen in the mean changes from baseline in plasma HIV-1 RNA at week 48. To compare at week 24 and 48, in the 2 UK-427,857 regimens versus placebo regimen: - the percentage of subjects with HIV-1 RNA less than 400 and 50 copies/mL . - the percentage of subjects who achieve a 0.5 log10 and 1.0 log10 reduction in HIV-1 RNA. - the differences in the magnitude of changes in CD4 and CD8. - the time-averaged difference in log10 HIV RNA. To compare at week 48 the time-to-loss of virologic response. To assess the association between baseline resistance and virologic response. To compare safety and tolerability of UK-427,857 when added to OBT versus OBT alone.;Primary end point(s): Change from baseline to 24 weeks in HIV-1 RNA measured on a logarithmic (based 10) scale. | — |
Countries
Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed