TABLE 4.
CRA trials that used the Trofile assay at patient screening or baseline and/or during treatment
| Company | Agent | Status | Trial name | Antiretroviral experience | Baseline tropism | Anti-HIV regimenb |
|---|---|---|---|---|---|---|
| GSK | Aplaviroc (APV) | Phase II complete | CCR100136 | No | R5 | LPV/r + APV |
| Phase II complete | CCR102881 | Yes | R5 | ZDV-3TC + EFV vs. ZDV-3TC + APV | ||
| Phase III on hold | CCR104627a | Yes | R5 and DM | OB vs. OB + APV | ||
| Pfizer | Maraviroc (MVC) | Phase III ongoing | A4001026 | No | R5 | 3TC-ZDV + EFV vs. 3TC-ZDV + MVC |
| A4001027c | Yes | R5 | OB vs. OB + MVC | |||
| A4001028d | Yes | R5 | OB vs. OB + MVC | |||
| A4001029 | Yes | DM | OB vs. OB + MVC | |||
| Schering-Plough | Vicriviroc (VCV) | Phase II ongoing | P03802 | No | R5 | 3TC-ZDV + EFV vs. 3TC-ZDV + VCV |
| ACTG5211 | Yes | R5 | OB + VCV | |||
| Progenics | Pro140 | Phase Ib ongoing | Pro140 1302 | No | R5 | Pro140 (monotherapy) |
| AnorMED | AMD11070 | Phase I complete | XACT | No | X4 | AMD11070 (monotherapy) |
| Phase II ongoing | ACTG5210 | No | X4 | AMD11070 (monotherapy) |
a
Screening study. After screening, the subjects were enrolled in phase III trials: CCR104458-R5/X4, CCR104456-R5, and CCR102709-R5.
b
OB, optimized background therapy; ZDV, zidovudine; 3TC, lamivudine; LPV/r, ritonavir-boosted lopinavir; EFV, efavirenz; APV, amprenavir.
c
United States and Canada.
d
Europe, Australia, and Brazil.