CLINICAL TRIALS PROFILE FOR RINTATOLIMOD

Clinical Trials for Rintatolimod

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00035581 ↗	Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART	Terminated	AIM ImmunoTech Inc.	Phase 2	This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
NCT00035581 ↗	Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART	Terminated	Hemispherx Biopharma	Phase 2	This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
NCT00035893 ↗	The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART	Completed	AIM ImmunoTech Inc.	Phase 2	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.
NCT00035893 ↗	The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART	Completed	Hemispherx Biopharma	Phase 2	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.
NCT00215813 ↗	Ampligen in Chronic Fatigue Syndrome	Available	AIM ImmunoTech Inc.		This is an open label study of Ampligen in patients with chronic fatigue syndrome.
NCT00215813 ↗	Ampligen in Chronic Fatigue Syndrome	Available	Hemispherx Biopharma		This is an open label study of Ampligen in patients with chronic fatigue syndrome.

Clinical Trial Conditions for Rintatolimod

Condition Name

Condition Name for
Intervention	Trials
HIV Infection	2
Anatomic Stage IV Breast Cancer AJCC v8	2
Progesterone Receptor Negative	2
HIV Seropositivity	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Breast Neoplasms	5
Carcinoma	4
Triple Negative Breast Neoplasms	4
Colorectal Neoplasms	4

Clinical Trial Locations for Rintatolimod

Trials by Country

Trials by Country for
Location	Trials
United States	30

Trials by US State

Trials by US State for
Location	Trials
New York	9
Pennsylvania	6
New Jersey	2
Florida	2
District of Columbia	2

Clinical Trial Progress for Rintatolimod

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	10
Phase 1/Phase 2	7
Phase 1	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	6
Recruiting	4
Completed	4

Clinical Trial Sponsors for Rintatolimod

Sponsor Name

Sponsor Name for
Sponsor	Trials
Roswell Park Cancer Institute	10
AIM ImmunoTech Inc.	10
National Cancer Institute (NCI)	9

Sponsor Type

Sponsor Type for
Sponsor	Trials
Other	18
Industry	18
NIH	9