December 1999/January 2000
Other participants in the Phase II clinical trial showed elevated enzyme levels, which may indicate kidney and liver damage.
The multicenter, placebo-control clinical trial of lodenosine was comparing three dosages of lodenosine, manufactured by U.S. Bioscience, Inc., to two approved antiretrovirals. At the time the trial was stopped, 176 people in three countries were taking lodenosine.
It was U.S. Bioscience, Inc. who told the U.S. Food and Drug Administration that the trial should be stopped pending review of all scientific information.
According to study data reported at ICAAC, 55 percent of the 66 participants taking lodenosine with two other antiretrovirals showed a reduction in viral load to below levels of detection after 12 weeks of use. The remaining 45 percent of the participants took 3TC.
While stopping short of stating that lodenosine caused the participant's death, U.S. Bioscience representatives admitted that an investigation was warranted.