NCT00035581

Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AIM ImmunoTech Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV Seropositivity
• HIV Infection

Interventions

Type	Name	Description
DRUG	poly I-poly C12U	200-400 mg IV infusions 2x/week for 24 weeks

Timeline

• Start date: 2001-05-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2002-05-06
• Last updated: 2013-04-17

Locations

7 sites across 1 country: United States