The program will evaluate the effect of Ampligen in patients infected by HIV-1 (with or without co-infection by hepatitis C virus) and virological failure with a randomized pilot study in phase II, controlled with standard treatment.
In March 2002, Hemispherx SA, a subsidiary of Hemispherx Biopharma, entered into a sales and distribution agreement with Esteve. Under this agreement, Esteve was granted the exclusive right to market Ampligen in Spain, Portugal and Andorra for the treatment of chronic fatigue syndrome (CFS).
In addition to other terms and projected payments, Esteve agreed to conduct, at its expense, certain clinical trials using Ampligen in the patient population co-infected with hepatitis C and HIV viruses.
At present, no single drug or biological product has been deemed by internationally recognized regulatory agencies as effective against both viruses, when coexisting in the same patients.