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

Sponsor

AIM ImmunoTech Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00035581

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity HIV Infection	Drug: poly I-poly C12U	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ampligen Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks	Drug: poly I-poly C12U 200-400 mg IV infusions 2x/week for 24 weeks Other Names: Ampligen Rintatolimod
No Intervention: No Ampligen No Ampligen administered for first 24 weeks

Arm

Intervention/Treatment

Experimental: Ampligen

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

Drug: poly I-poly C12U

200-400 mg IV infusions 2x/week for 24 weeks

Other Names:

Ampligen

Rintatolimod

No Intervention: No Ampligen

No Ampligen administered for first 24 weeks

Outcome Measures

Primary Outcome Measures

Reduction in HIV-1 Viral Load [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Adults at least 18 years of age.
CD4 cell count of >300 cells.
HIV-1 plasma RNA >500 and <30,000 copies/ml.

A qualifying ("screening") HIV-1 RNA level >500 and <30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:

Abacavir (Ziagen)
Zidovudine (Retrovir) AZT
Zalcitabine (Hivid) ddC
Didanosine (Videx) ddI
Stavudine (Zerit) d4T
Efavirenz (Sustiva)
Indinavir (Crixivan)
Ritonavir (Norvir)
Nelfinavir (Viracept)
Amprenavir (Agenerase)

The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.

History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
Karnofsky performance status of at least 70.
The following laboratory parameters within 14 days prior to treatment:

Hemoglobin > 9.2 g/dL for men and > 8.9 g/dL for women
Neutrophil count > 1000
Platelet count > 75,000
AST/ALT < 4.0 x upper limit of normal (ULN)
Serum creatinine < 1.5 x ULN or a creatinine clearance > 50 mL/min.

For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Center for Special Immunology	Fountain Valley	California	United States	92708
2	Circle Medical Center	Norwalk	Connecticut	United States	06851
3	Dupont Circle Physicians Group	Washington	District of Columbia	United States	20009
4	Julia Torres, MD	Fort Lauderdale	Florida	United States	33306
5	Scott Ubillos, MD	Tampa	Florida	United States	33607
6	St. Michael's Medical Center	Newark	New Jersey	United States	07102
7	W. Chris Woodward, DO	Reading	Pennsylvania	United States	19601