Compositions and Methods for Determining Whether a Subject Would Benefit from Co-Receptor Inhibitor Therapy

A method for determining whether a subject infected with a dual-mixed tropic population of human immunodeficiency viruses (HIV) would benefit from CXCR4-inhibitor or CCR5-inhibitor therapy, comprising:

• a. determining whether the population is a homogeneous or heterogeneous population;
• wherein if the population is a homogeneous population, step b but not step c of the method is performed, and wherein if the population is a heterogeneous population, step c but not step b of the method is performed;
• b. determining whether the homogeneous population is Dual_R tropic or CXCR4-tropic or neither, wherein if the homogeneous population is Dual_R tropic, the subject would benefit from CCR5-inhibitor therapy, wherein if the homogeneous population is Dual_X tropic, the subject would benefit from CXCR4-inhibitor therapy, and wherein if the homogeneous population is neither Dual_R tropic nor CXCR4-tropic, the subject would not benefit from either CCR5-inhibitor or CXCR4-inhibitor therapy;
• and
• c. determining the relative proportions of CCR5-tropic, CXCR4-tropic, Dual_R tropic, Dual_X tropic, or dual tropic HIV of the heterogeneous population, wherein
• i. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic and CXCR4-tropic and/or Dual_X tropic HIV and comprises substantially more CCR5-tropic and/or Dual_R tropic HIV than CXCR4-tropic and/or Dual_X tropic HIV, the subject would benefit from CCR5-inhibitor therapy;
• ii. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic and CXCR4-tropic and/or Dual_X tropic HIV and comprises comparable amounts of CCR5-tropic and/or Dual_R tropic and CXCR4-tropic and/or Dual_X tropic HIV, the subject would not benefit from either CCR5-inhibitor or CXCR4-inhibitor therapy;
• iii. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic and CXCR4-tropic and/or Dual_X tropic HIV and comprises substantially more CXCR4-tropic and/or Dual_X tropic HIV than CCR5-tropic and/or Dual_R tropic HIV, the subject would benefit from CXCR4-inhibitor therapy;
• iv. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic and dual-tropic HIV and comprises substantially more CCR5-tropic and/or Dual_R tropic HIV than dual-tropic HIV, the subject would benefit from CCR5-inhibitor therapy;
• v. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic and dual-tropic HIV and comprises relatively comparable amounts of CCR5-tropic and/or Dual_R tropic HIV and dual-tropic HIV or comprises substantially more dual-tropic HIV than CCR5-tropic and/or Dual_R tropic HIV, the subject would not benefit from CCR5-inhibitor therapy;
• vi. if the heterogeneous population contains CXCR4-tropic and/or Dual_X tropic and dual-tropic HIV and comprises substantially more CXCR4-tropic and/or Dual_X tropic HIV than dual-tropic HIV, the subject would benefit from CXCR4-inhibitor therapy;
• vii. if the heterogeneous population contains CXCR4-tropic and/or Dual_X tropic and dual-tropic HIV and comprises relatively comparable amounts of CXCR4-tropic and/or Dual_X tropic HIV and dual-tropic HIV or comprises substantially more dual-tropic HIV than CXCR4-tropic and/or Dual_X tropic HIV, the subject would not benefit from either CXCR4-inhibitor or CCR5-inhibitor therapy;
• viii. if the heterogeneous population contains CCR5-tropic and/or
• Dual_R tropic, CXCR4-tropic and/or Dual_X tropic, and dual-tropic HIV and comprises substantially more CCR5-tropic and/or Dual_R tropic HIV than CXCR4-tropic and/or Dual_X tropic and dual-tropic HIV, the subject would benefit from CCR5-inhibitor therapy;
• ix. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic, CXCR4-tropic and/or Dual_X tropic, and dual-tropic HIV and comprises relatively comparable amounts of CCR5-tropic and/or Dual_R tropic HIV and CXCR4-tropic and/or Dual_X tropic and dual-tropic HIV, the subject would not benefit from either CCR5-inhibitor or CXCR4-inhibitor therapy;
• and
• x. if the heterogeneous population contains CCR5-tropic and/or Dual_R tropic, CXCR4-tropic and/or Dual_X tropic, and dual-tropic HIV and comprises substantially more CXCR4-tropic and/or Dual_X tropic HIV than CCR5-tropic and/or Dual_R tropic and dual-tropic HIV, the subject would benefit from CXCR4-inhibitor therapy.