Hepatitis C and HIV: Ribavirin Plus Interferon Study Recruiting
AmFAR (the American Foundation for AIDS Research) is now beginning the first study of treating hepatitis C in persons who also have HIV. Trial sites are now opening in 14 U.S. cities, and a few others may be added.
Volunteers will be randomly assigned to either interferon alpha-2b plus ribavirin, or to the interferon alone (plus a ribavirin placebo). However, those assigned to monotherapy who have detectable virus at week 12 will be assigned to combination treatment starting at week 16; this assignment will be blinded, so volunteers will not know if their regimen has changed. The drug treatment period will last for 48 weeks, with followup for 28 weeks after that.
Volunteers must be HIV-positive and have hepatitis C disease, be at least 18 years of age, and been on stable FDA-approved treatment for HIV (or on no treatment for HIV) for at least four weeks. This study does not have CD4 count or HIV viral load requirements. However, there are 29 exclusion criteria (mostly for specific medical conditions or medications)--which may make it difficult to recruit the 200 volunteers being sought.
Also, this trial will only pay for the ribavirin and the hepatitis C viral load tests; volunteers are responsible for the other costs. For those unable to afford the interferon, it is being made available through Schering Plough's patient assistance program. (Schering Plough, which has the rights to distribute ribavirin for hepatitis C in the U.S. and which also markets interferon alpha-2b, is providing partial funding for this study.)
The trial will be conducted at medical centers in the following cities:
East: Baltimore, Hershey, Newark, New York, Philadelphia, Providence;
South: Atlanta, Chapel Hill, Miami;
Midwest: St. Paul, Wichita;
West: Los Angeles, Portland, Sacramento.
AmFAR also hopes to open about three more sites in other cities, including San Francisco.
For more information, call Jeffery Smith at AmFAR, 602-340-1207, who can discuss the trial in more detail and refer you to one of the sites listed above.
