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

Study Overview
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Brief Summary
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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).

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

Conditions
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HIV Seropositivity, HIV Infection

Intervention / Treatment
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* Drug: poly I-poly C12U


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ampligen<br>Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks | Drug: poly I-poly C12U<br>* 200-400 mg IV infusions 2x/week for 24 weeks<br>* Other names: Rintatolimod;|
| No Intervention: No Ampligen<br>No Ampligen administered for first 24 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in HIV-1 Viral Load | 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. | 4, 8, 12, 16, 20 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment experienced, HIV Infections, HIV, HAART, early virologic failure