Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infection HIV Seropositivity

Keywords

treatment experiencedHIV InfectionsHIVHAARTearly 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 C12UDrug

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

Also known as: Ampligen, Rintatolimod

Ampligen

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

AIM ImmunoTech Inc.
Industrylead

Study Sites (7)

Orange County Center for Special Immunology

Fountain Valley, California, 92708, United States

Circle Medical Center

Norwalk, Connecticut, 06851, United States

Dupont Circle Physicians Group

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

Julia Torres, MD

Fort Lauderdale, Florida, 33306, United States

Scott Ubillos, MD

Tampa, Florida, 33607, United States

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

W. Chris Woodward, DO

Reading, Pennsylvania, 19601, United States

MeSH Terms

Conditions

HIV SeropositivityHIV Infections

Interventions

poly(I).poly(c12,U)

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Study Officials

David R Strayer, MD
AIM ImmunoTech Inc.
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

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 2001

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Ampligen

No Ampligen

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Ampligen

No Ampligen

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations