Arizona Trial Examines Efficacy of Merck’s Antiretroviral Raltegravir
The Tucson Citizen on Monday examined a worldwide trial of Merck's antiretroviral drug raltegravir based at the El Rio Community Health Center in Arizona. The trial, which is sponsored by Merck, includes participants who have become resistant to other treatments. According to the Citizen, the study includes 40 different clinics in the U.S., as well as clinics in South America and Europe. Each clinic participating in the trial has six participants in the study, the Citizen reports (Rowley, Tucson Citizen, 3/24).
FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA. Raltegravir is sold under the brand name Isentress (Kaiser Daily HIV/AIDS Report, 10/15/07).
Fritz Bredeek -- principle investigator for the study in Arizona and a physician at the El Rio HIV Clinic -- said that the study participants "were the least treatable" when they enrolled. Kevin Carmichael, head of the El Rio HIV Clinic, said that he saw HIV-positive people "who were failing therapy." He added that they were "dying" and that raltegravir "saved their lives." Bredeek said that when FDA reviews the results of the study at the 48-week mark, he believes the drug will be approved for use by all people living with HIV/AIDS.
Robin Isaacs, Merck's director of clinical research, said that an unrelated study is under way to examine the effects of raltegravir among people who have never taken antiretrovirals. Those results will be presented to FDA at the end of the year, the Citizen reports (Tucson Citizen, 3/24).