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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
200-400 mg IV infusions 2x/week for 64 weeks
Orange County Center for Special Immunology
Fountain Valley, California, United States
AltaMed Health Services Corporation
Los Angeles, California, United States
Circle Medical Center
Norwalk, Connecticut, United States
HAART-free time interval
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
Time frame: HAART adherence questionnaire completed weekly
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Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Julia Torres, MD
Fort Lauderdale, Florida, United States
Allied Clinical Trials
Miami, Florida, United States
Scott Ubillos, MD
Tampa, Florida, United States
St. Michael's Medical Center
Newark, New Jersey, United States
Christopher Lucasti, D.O.
Somers Point, New Jersey, United States
W. Chris Woodward, DO
Reading, Pennsylvania, United States