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

NCT00035893 | Completed Phase 2

• 1 other identifier: AMP 720
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

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

Conditions

HIV Seropositivity; HIV Infection

Keywords

treatment interruption; HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ampligen

EXPERIMENTAL

Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.

Drug: poly I-poly C12U

No Ampligen

NO INTERVENTION

No Ampligen administered for first 64 weeks

Interventions

poly I-poly C12U DRUG

200-400 mg IV infusions 2x/week for 64 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 \> 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.

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 (10)

Orange County Center for Special Immunology

Fountain Valley, California, 92708, United States

Location

AltaMed Health Services Corporation

Los Angeles, California, 90022, 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

Allied Clinical Trials

Miami, Florida, 33156, United States

Location

Scott Ubillos, MD

Tampa, Florida, 33607, United States

Location

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

Christopher Lucasti, D.O.

Somers Point, New Jersey, 08244, 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 6, 2002
• First Posted: May 7, 2002
• Study Start: May 1, 2001
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (10)