Fuzeon Viral Decay Pilot Study

Inclusion criteria

• Patient must be HIV infected
• Patient must be > 18 years old
• Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
• Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
• Patient must have a CD4 count above 400 cells/mm3 in last 3 months
• Female patient must agree to use two methods of birth control or abstinence during the period of the study
• Patient has to have signed full informed consent

Exclusion criteria

• Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
• Patient who have taken mono or dual antiretroviral therapy
• Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
• Patient with any of the following abnormal laboratory test results in screening:

• Hemaglobin < 100 g/L
• Neutrophil count < 750 cells/uL
• Platelet count < 50,000 cells/L
• AST or ALT > 5X the upper limit of normal
• Creatinine > 250 umol/L
• Patient with a malignancy
• Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
• Patient with an active AIDS-defining illnesses in the past six months
• Patients who are pregnant