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poly I-poly C12U

Phase 2

HIV Seropositivity | Small molecule | Infectious Disease |AIM ImmunoTech Inc.|Last Updated: Apr 17, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

poly I-poly C12U · 1 trial · 2 indications

Phase 2 1
NCT00035893The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAARTHIV Seropositivity
COMPLETED40 Analytics
PHASE2COMPLETED
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
HIV SeropositivityUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AmpligenEXPERIMENTALAmpligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.
No AmpligenNO_INTERVENTIONNo Ampligen administered for first 64 weeks

Interventions

NameTypeDescription
poly I-poly C12UDRUG200-400 mg IV infusions 2x/week for 64 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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Frequently asked questions about poly I-poly C12U

What is poly I-poly C12U used for?

Poly I-poly C12U, also known as Ampligen, is an investigational small molecule being studied for the treatment of HIV seropositivity and HIV infection. It is being developed by AIM ImmunoTech Inc. (AIM) and is currently in Phase 2 clinical development.

What does poly I-poly C12U target?

Poly I-poly C12U is a double-stranded RNA molecule that acts as a Toll-like receptor 3 (TLR3) agonist. It is designed to modulate the immune system by stimulating innate immune responses, which may help in the treatment of HIV infection.

Who makes poly I-poly C12U?

Poly I-poly C12U is being developed by AIM ImmunoTech Inc., a biopharmaceutical company listed on the NYSE American under the ticker symbol AIM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in HIV-infected patients.

What phase is poly I-poly C12U in?

Poly I-poly C12U is currently in Phase 2 clinical development for the treatment of HIV seropositivity. It is an investigational drug and has not been approved by the FDA. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is poly I-poly C12U in?

Poly I-poly C12U has been studied in one completed Phase 2 clinical trial, NCT00035893, titled 'The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART.' This trial enrolled 40 participants with HIV seropositivity and HIV infection in the United States.

Is poly I-poly C12U the same as Ampligen?

Yes, poly I-poly C12U is also known as Ampligen. The drug is being developed by AIM ImmunoTech Inc. under the brand name Ampligen for the treatment of HIV infection and other conditions.