Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

Inclusion Criteria

• •1. Adults at least 18 years of age.
• •2. CD4 cell count of \>300 cells.
• •3. HIV-1 plasma RNA \>500 and \<30,000 copies/ml.
• •A qualifying ("screening") HIV-1 RNA level \>500 and \<30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:
• •* Abacavir (Ziagen)
• •* Zidovudine (Retrovir) AZT
• •* Zalcitabine (Hivid) ddC
• •* Didanosine (Videx) ddI
• •* Stavudine (Zerit) d4T
• •* Efavirenz (Sustiva)
• •* Indinavir (Crixivan)
• •* Ritonavir (Norvir)
• •* Nelfinavir (Viracept)
• •* Amprenavir (Agenerase)
• •The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.
• •4. History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
• •5. Karnofsky performance status of at least 70.
• •6. The following laboratory parameters within 14 days prior to treatment:
• •* Hemoglobin \> 9.2 g/dL for men and \> 8.9 g/dL for women
• •* Neutrophil count \> 1000
• •* Platelet count \> 75,000
• •* AST/ALT \< 4.0 x upper limit of normal (ULN)
• •* Serum creatinine \< 1.5 x ULN or a creatinine clearance \> 50 mL/min.
• •7. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.