Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
- Conditions
- HIV SeropositivityHIV Infection
- Interventions
- Drug: poly I-poly C12U
- Registration Number
- NCT00035581
- Lead Sponsor
- AIM ImmunoTech Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ampligen poly I-poly C12U Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks
- Primary Outcome Measures
Name Time Method Reduction in HIV-1 Viral Load 4, 8, 12, 16, 20 and 24 Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Orange County Center for Special Immunology
🇺🇸Fountain Valley, California, United States
Julia Torres, MD
🇺🇸Fort Lauderdale, Florida, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Circle Medical Center
🇺🇸Norwalk, Connecticut, United States
Scott Ubillos, MD
🇺🇸Tampa, Florida, United States
W. Chris Woodward, DO
🇺🇸Reading, Pennsylvania, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States