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

NCT00035581 | Terminated Phase 2

• 1 other identifier: AMP 719
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 7

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).

Conditions

HIV Seropositivity; HIV Infection

Keywords

treatment experienced; HIV Infections; HIV; HAART; early virologic failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ampligen

EXPERIMENTAL

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

Drug: poly I-poly C12U

No Ampligen

NO INTERVENTION

No Ampligen administered for first 24 weeks

Interventions

poly I-poly C12U DRUG

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

Also known as: Ampligen, Rintatolimod

Ampligen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Adults at least 18 years of age. 2. CD4 cell count of \>300 cells. 3. 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. 4. 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). 5. Karnofsky performance status of at least 70. 6. 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. 7. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead

Study Sites (7)

Orange County Center for Special Immunology

Fountain Valley, California, 92708, United States

Location

Circle Medical Center

Norwalk, Connecticut, 06851, United States

Location

Dupont Circle Physicians Group

Washington D.C., District of Columbia, 20009, United States

Location

Julia Torres, MD

Fort Lauderdale, Florida, 33306, United States

Location

Scott Ubillos, MD

Tampa, Florida, 33607, United States

Location

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

W. Chris Woodward, DO

Reading, Pennsylvania, 19601, United States

Location

MeSH Terms

Conditions

HIV Seropositivity; HIV Infections

Interventions

poly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• David R Strayer, MD

  AIM ImmunoTech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: May 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (7)