RintatolimodOther Names: AMP, Ampligen, Atvogen, poly(I)-poly(C12U), poly(I:C12U), polyI:polyC12U Drug Class: Immune Modulators Molecular Formula: (C10 H13 N4 O8 P)x.(C9 H14 N3 O8 P.C9 H13 N2 O9 P)x Registry Number: 38640-92-5 (CAS) Chemical Name: 5'-Inosinic acid, homopolymer, complex with 5'-cytidylic acid polymer with 5'-uridylic acid (1:1)
Chemical Class: Oligonucleotides Organization: Hemispherx; Rega Institute for Medical Research Phase of Development: Rintatolimod is in Phase IIb development for HIV treatment.
(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 IAS 2003 Abstract 596,3 and Immunotherapy article4)
What is rintatolimod?
Rintatolimod is anthat is being studied for HIV treatment. As an HIV investigational drug, rintatolimod is categorized as an immune modulator.3,4 (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function.
Researchers have studied the safety and effectiveness of rintatolimod during an analytical treatment interruption (ATI). An ATI is when HIV medicines are stopped for a time during ato evaluate how well an investigational drug can maintain control of a participant’s during the ATI.3,5
Which clinical trials are studying rintatolimod?
Study Names: AMP 720; NCT00035893
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety and effectiveness of rintatolimod given during an ATI in people with well-controlled HIV on ART.3,5
For more details on this study, see the Health Professional version of this drug summary.
Another Phase II study of rintatolimod (AMP 719; NCT00035581) was stopped before it was completed. In AMP 719, investigators were planning to study the safety and effectiveness of adding twice weekly rintatolimod to ART in people whose HIV was not well controlled by ART.6
What side effects might rintatolimod cause?
One goal of HIV research is to identify new drugs that have fewer side effects. In the AMP 720 study (NCT00035893), side effects with use of AMP were generally mild and cleared up without treatment.3,5
Information on possible side effects of rintatolimod is not complete. As testing of rintatolimod continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying rintatolimod?
More information about rintatolimod-related research studies is available from ClinicalTrials.gov.
- United States National Library of Medicine. ChemIDplus Advanced: Rintatolimod. https://chem.nlm.nih.gov/chemidplus/rn/38640-92-5. Accessed December 28, 2018.
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed December 28, 2018.
- Blick G, Greiger-Zanlungo P, Strayer DR, Mitchell WM, Carter WA. Interim results of AMP720: a Phase IIb prospective, randomized, controlled study evaluating the immunomodulatory role of ampligen (poly I:poly C12U) against HIV during STI. International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment; July 13-16, 2003; Paris, France. Abstract 596. http://www.abstract-archive.org/Abstract/Share/37573. Accessed December 28, 2018.
- Nicodemus CF, Berek JS. TLR3 agonists as immunotherapeutic agents. Immunotherapy. 2010;2(2). https://www.futuremedicine.com/doi/full/10.2217/imt.10.8. Accessed December 28, 2018.
- Hemispherx Biopharma. 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. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 6, 2002. NLM Identifier: NCT00035893. https://www.clinicaltrials.gov/ct2/show/NCT00035893. Accessed December 28, 2018.
- Hemispherx Biopharma. A multi-center, randomized, controlled study of the biological actions of Ampligen as an adjunct to HAART in HIV disease. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 3, 2002. NLM Identifier: NCT00035581. https://www.clinicaltrials.gov/ct2/show/NCT00035581. Accessed December 28, 2018.
Last Reviewed: January 17, 2019