The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
- Conditions
- HIV SeropositivityHIV Infection
- Interventions
- Drug: poly I-poly C12U
- Registration Number
- NCT00035893
- 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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ampligen poly I-poly C12U Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.
- Primary Outcome Measures
Name Time Method HAART-free time interval HAART adherence questionnaire completed weekly To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
AltaMed Health Services Corporation
🇺🇸Los Angeles, California, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Allied Clinical Trials
🇺🇸Miami, Florida, United States
Orange County Center for Special Immunology
🇺🇸Fountain Valley, California, United States
Circle Medical Center
🇺🇸Norwalk, Connecticut, United States
Julia Torres, MD
🇺🇸Fort Lauderdale, Florida, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Christopher Lucasti, D.O.
🇺🇸Somers Point, New Jersey, United States
Scott Ubillos, MD
🇺🇸Tampa, Florida, United States
W. Chris Woodward, DO
🇺🇸Reading, Pennsylvania, United States