Triangle trial put on hold

VIRS said that the FDA issued a clinical hold on VIRS's South African Phase II/III trial comparing its Coviracil emtricitabine nucleoside analog to BioChem Pharma Inc.'s Epivir lamivudine 3TC to treat HIV infection/AIDS. The agency is awaiting the outcome of discussions between VIRS and the South African Medicines Control Council over future management of patients in the trial, VIRS said. The company previously stopped enrolling patients in the trial, which is being conducted under a U.S. IND, due to a higher-than-expected incidence of liver toxicity, including two deaths, among the 470 patients enrolled to date (see BioCentury Extra, April 6). Patients in the trial also are receiving Bristol-Myers Squibb Co.'s Zerit stavudine d4T plus Boehringer Ingelheim's Viramune nevirapine or DuPont's Sustiva efavirenz non-nucleoside reverse transcriptase inhibitors (NNRTIs). ...