The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

HIV Infection Clinical Trial

Official title:

The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035893
• Other study ID #: AMP 720
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2002
• Last updated: April 16, 2013
• Start date: May 2001
• Est. completion date: August 2006

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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• 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 > 400 cells.

3. Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.

4. History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:

• Abacavir (Ziagen)

• Zidovudine (Retrovir) AZT

• Zalcitabine (Hivid) ddC

• Didanosine (Videx) ddl

• Stavudine (Zerit) d4T

• Efavirenz (Sustiva)

• Indinavir (Crixivan)

• Ritonavir (Norvir)

• Nelfinavir (Viracept)

• Amprenavir (Agenerase)

Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.

5. Karnofsky performance status of at least 70.

6. The following laboratory parameters within 21 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. Ability and willingness to give written informed consent.

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

9. The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.

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 64 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	AltaMed Health Services Corporation	Los Angeles	California
United States	Allied Clinical Trials	Miami	Florida
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	Christopher Lucasti, D.O.	Somers Point	New Jersey
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	HAART-free time interval	To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.	HAART adherence questionnaire completed weekly	Yes