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

AIM ImmunoTech Inc.7 sites in 1 country16 target enrollmentMay 2001

ConditionsHIV Seropositivity HIV Infection

Interventionspoly I-poly C12U

Drugspoly I-poly C12U

Overview

Phase: Phase 2
Intervention: poly I-poly C12U
Conditions: HIV Seropositivity
Sponsor: AIM ImmunoTech Inc.
Enrollment: 16
Locations: 7
Primary Endpoint: Reduction in HIV-1 Viral Load
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).

Registry

clinicaltrials.gov

Start Date

May 2001

End Date

September 2005

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AIM ImmunoTech Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Ampligen

Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks

Intervention: poly I-poly C12U

Outcomes

Primary Outcomes

Reduction in HIV-1 Viral Load

Time Frame: 4, 8, 12, 16, 20 and 24

Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.