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

Sponsor

AIM ImmunoTech Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00035893

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity HIV Infection	Drug: poly I-poly C12U	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ampligen Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.	Drug: poly I-poly C12U 200-400 mg IV infusions 2x/week for 64 weeks Other Names: Ampligen Rintatolimod
No Intervention: No Ampligen No Ampligen administered for first 64 weeks

Arm

Intervention/Treatment

Experimental: Ampligen

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

Drug: poly I-poly C12U

200-400 mg IV infusions 2x/week for 64 weeks

Other Names:

Ampligen

Rintatolimod

No Intervention: No Ampligen

No Ampligen administered for first 64 weeks

Outcome Measures

Primary Outcome Measures

HAART-free time interval [HAART adherence questionnaire completed weekly]
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Adults at least 18 years of age.
CD4 cell count of > 400 cells.
Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
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.

Karnofsky performance status of at least 70.
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.

Ability and willingness to give written informed consent.
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.
The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Center for Special Immunology	Fountain Valley	California	United States	92708
2	AltaMed Health Services Corporation	Los Angeles	California	United States	90022
3	Circle Medical Center	Norwalk	Connecticut	United States	06851
4	Dupont Circle Physicians Group	Washington	District of Columbia	United States	20009
5	Julia Torres, MD	Fort Lauderdale	Florida	United States	33306
6	Allied Clinical Trials	Miami	Florida	United States	33156
7	Scott Ubillos, MD	Tampa	Florida	United States	33607
8	St. Michael's Medical Center	Newark	New Jersey	United States	07102
9	Christopher Lucasti, D.O.	Somers Point	New Jersey	United States	08244
10	W. Chris Woodward, DO	Reading	Pennsylvania	United States	19601