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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00035581
• Other study ID #: AMP 719
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2002
• Last updated: April 16, 2013
• Start date: May 2001
• Est. completion date: September 2005

Study information

• Verified date: April 2013
• Source: Hemispherx Biopharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• HIV Seropositivity

Intervention

Drug:
• poly I-poly C12U
200-400 mg IV infusions 2x/week for 24 weeks

Locations

Country	Name	City	State
United States	Julia Torres, MD	Fort Lauderdale	Florida
United States	Orange County Center for Special Immunology	Fountain Valley	California
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Circle Medical Center	Norwalk	Connecticut
United States	W. Chris Woodward, DO	Reading	Pennsylvania
United States	Scott Ubillos, MD	Tampa	Florida
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hemispherx Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No