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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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-Fr

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 Summary:
Sponsor: Hemispherx Biopharma

Current Primary Outcome: HAART-free time interval [ Time Frame: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hemispherx Biopharma

Dates:
Date Received: May 6, 2002
Date Started: May 2001
Date Completion:
Last Updated: April 16, 2013
Last Verified: April 2013