NCT00035893

The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400.

Conditions

• HIV Seropositivity
• HIV Infection

Interventions

Type	Name	Description
DRUG	poly I-poly C12U	200-400 mg IV infusions 2x/week for 64 weeks

Timeline

• Start date: 2001-05-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2002-05-07
• Last updated: 2013-04-17

Locations

10 sites across 1 country: United States