Johnson and Johnson seeks patients for Grace study

Tibotec Therapeutics, a division of Ortho Biotech Products and a member of the Johnson & Johnson family of companies, has announced that it is seeking African-American women who have received treatment for HIV for participation in its gender, race and clinical experience (Grace) study.

Over a 48-week treatment period, the phase III clinical trial will investigate the effect of gender and ethnicity differences on the safety, tolerability and efficacy of Prezista (darunavir) tablets given to patients in conjunction with ritonavir and other retrovirals.

Prezista was developed by Tibotec Pharmaceuticals and is marketed by Tibotec Therapeutics.

Debbie Hagins, an investigator in the study, said: “We expect Grace will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of colour, especially in the earliest stages of new antiretroviral agents.”

She added that, despite being aware of gender and ethnicity-specific complications related to HIV, the medical community was unaware of the implications of gender and ethnicity on the adverse effects profile and efficacy of medications for the virus.

In December 2006, Prezista received a positive opinion for the treatment of HIV from the European Committee for Human Medicinal Products.