This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).

Condition	Treatment or Intervention	Phase
HIV Seropositivity HIV Infection	Drug: (Ampligen) polyI-polyC12U	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Orange County Center for Special Immunology, Fountain Valley,  California,  92708,  United States; Recruiting
Connecticut
      Circle Medical Center, Norwalk,  Connecticut,  06851,  United States; Recruiting
District of Columbia
      Dupont Circle Physicians Group, Washington,  District of Columbia,  20009,  United States; Recruiting
Florida
      Julia Torres, MD, Fort Lauderdale,  Florida,  33306,  United States; Recruiting
      Scott Ubillos, MD, Tampa,  Florida,  33607,  United States; Recruiting
New Jersey
      St. Michael's Medical Center, Newark,  New Jersey,  07102,  United States; Recruiting
New York
      AIDS Community Research Initiative of America (ACRIA), New York,  New York,  10018,  United States; Recruiting
Pennsylvania
      W. Chris Woodward, DO, Reading,  Pennsylvania,  19601,  United States; Recruiting

Study ID Numbers:  AMP 719
Record last reviewed:  September 2002
Record first received:  May 3, 2002
ClinicalTrials.gov Identifier:  NCT00035581
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10