Vivecon, an experimental HIV maturation inhibitor is entering Phase IIA clinical trials involving HIV-positive patients who have never taken anti-HIV drugs before, developer Myriad Genetics has announced.
Completed Phase I studies involving HIV-negative individuals showed that the drug was safe. A total of 55 individuals were enrolled in this study, with different doses of the drug tested in nine separate cohorts. No serious side-effects were reported, nor were there any significant changes in blood chemistry or heart function as measured by ECG.
The Phase I study also showed that the doses of Vivecon studied achieved levels in the blood capable of inhibiting HIV. Encouragingly, good levels of Vivecon in the blood were achieved when it was dosed with food. Preliminary laboratory tests have already suggested that the drug has an anti-HIV effect, including against virus that is resistant to drugs from both the non-nucleoside reverse transcriptase and protease inhibitor classes.
Vivecon will now enter Phase IIA clinical trials. Different doses of the drug will be studied in HIV-positive patients who have not taken antiretroviral therapy before. Investigators will be examining the safety, anti-HIV effect, and pharmacokinetics of the drug.
Another maturation inhibitor, Panacos’s bevirimat, is in Phase IIb studies. Bevirimat has been slow to progress in clinical trials, due in part to dosing and formulation difficulties.