Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

• Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay [ Time Frame: Baseline, Day 4, 7, 14 ] [ Designated as safety issue: No ]
  Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism
  
  

• Subjects Achieving HIV-1 RNA <400 Copies/mL [ Time Frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 ] [ Designated as safety issue: Yes ]
  Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point
  
  
• Subjects Achieving HIV-1 RNA <50 Copies/mL [ Time Frame: Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 ] [ Designated as safety issue: Yes ]
  Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point
  
  
• Subjects With Virologic Failure [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]
  For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.
  
  
• Time to Virologic Failure [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
  For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.
  
  
• Change in Lymphocyte Subset CD4 From Baseline [ Time Frame: Day 1 (Baseline), Day 7, 14, 28 and Weeks 24 ] [ Designated as safety issue: Yes ]
  Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1
  
  
• Change in Lymphocyte Subset CD8 From Day 1 [ Time Frame: Day 1(Baseline), Day 7, 14, 28 and Weeks 24 ] [ Designated as safety issue: No ]
  Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1
  
  
• Change in Lymphocyte Subsets; CD4 and CD8 From Screening. [ Time Frame: Screening (Day -14 to 0), Day 1. ] [ Designated as safety issue: No ]
  Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}
  
  
• Change in Detectable Tropism From Screening [ Time Frame: Screening (Day -21 to 0), Baseline. ] [ Designated as safety issue: No ]
  Number of subjects who switch their tropism status from screening to Baseline
  
  
• Change in Detectable Tropism From Baseline [ Time Frame: Baseline, Day 15 and Week 24/End of Study/Discontinuation ] [ Designated as safety issue: No ]
  Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation
  
  
• Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening [ Time Frame: Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure. ] [ Designated as safety issue: No ]
  Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening
  
  
• Number of Subjects With Susceptibility to Maraviroc [ Time Frame: Screening (Day -21 to 0), Day 14, Week 24 ] [ Designated as safety issue: No ]
  Phenotypic susceptibility to maraviroc
  
  
• Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24 [ Time Frame: Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24 ] [ Designated as safety issue: No ]
  Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24
  
  
• Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc [ Time Frame: Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24 ] [ Designated as safety issue: No ]
  

The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.