This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.

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 > 400 cells.

3. Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.

4. History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:

• Abacavir (Ziagen)
• Zidovudine (Retrovir) AZT
• Zalcitabine (Hivid) ddC
• Didanosine (Videx) ddl
• Stavudine (Zerit) d4T
• Efavirenz (Sustiva)
• Indinavir (Crixivan)
• Ritonavir (Norvir)
• Nelfinavir (Viracept)
• Amprenavir (Agenerase)

Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.

5. Karnofsky performance status of at least 70.

6. The following laboratory parameters within 21 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. Ability and willingness to give written informed consent.

8. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Females of child bearing potential agree to use an effective means of contraception.

9. The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.

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 720
Record last reviewed:  September 2002
Record first received:  May 6, 2002
ClinicalTrials.gov Identifier:  NCT00035893
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10