TucaresolOther Names: 589C80 Drug Class: Immune Modulators Molecular Formula: C15 H12 O5 Registry Number: 84290-27-7 (CAS) Chemical Name: 4-[(2-formyl-3-hydroxy-phenoxy)methyl]benzoic acid Chemical Class: Benzoic Acids Organization: GlaxoSmithKline Phase of Development: II
(Compound details obtained from ChemIDplus Advanced1 and NIAID Therapeutics Database2)
What is an investigational drug?
Anis one that is under study and is not approved by the U.S. (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.
To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.
What is tucaresol?
Tucaresol is an investigational drug that is categorized as an immune modulator.2 Immune modulators (also called immunomodulators) are substances that modify (activate, enhance, or suppress) theor the functioning of the immune system.
Tucaresol was studied for its ability to help restore or boost the immune systems of HIV-infected individuals. The drug may help to repair damage that HIV has done to the immune system and to protect the long-term health of HIV-infected individuals.3
How are clinical trials of investigational drugs conducted?
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.4
- Phase I trials: Researchers test an investigational drug in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
- Phase II trials: The investigational drug is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
- Phase III trials: The investigational drug is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.4
In most cases, an investigational drug must be proven effective and must show continued safety in a Phase IIIto be considered for approval by FDA for sale in the United States. Some drugs go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug’s risks, benefits, and optimal use.4
In what phase of testing is tucaresol?
Tucaresol has been studied in a Phase II clinical trial.2
What are some studies on tucaresol?
Study Name: Not available
Participants: Four groups of HIV-infected participants were studied.
- Two groups of participants had never taken HIV medicines before entering the study (treatment-naive), while two other groups of participants had taken HIV medicines before entering the study ( ).
- The groups also differed according to the participants’ CD4 counts and levels. (Viral load is the amount of HIV in a blood sample. A is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)
Purpose: The purpose of this study was to look at the safety and immune-modulating effects of tucaresol in different groups of HIV-infected participants. In terms of immune-modulating effects, the study looked at whether tucaresol could increase the number and activity of certain cells of the immune system.3,5,6For more details on the study, see the Health Professional version.
What side effects might tucaresol cause?
In the Phase I/II study discussed under the previous question, the most common side effects that occurred in the treatment-experienced participants taking ART and tucaresol were low-grade fever and other mild constitutional symptoms. (Constitutional symptoms are symptoms affecting the whole body, such as fever and weight loss.)3
Information on possible side effects of tucaresol is not complete. As testing of tucaresol continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying tucaresol?
More information about tucaresol-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
How can I find more information about participating in a clinical trial?
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.4
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
- United States National Library of Medicine. ChemIDplus Advanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/rn/84290-27-7. Last accessed on June 24, 2016.
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: http://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on June 24, 2016.
- Gori A, Trabattoni D, Bandera A, et al. Immunomodulation induced by tucaresol in HIV infection: results of a 16 week pilot Phase I/II trial. Antivir Ther. 2004 Aug;9(4):603-14. Available at: http://www.intmedpress.com/serveFile.cfm?sUID=51adea26-5a12-4d62-bca1-3164eb7a9222. Last accessed on June 24,2016.
- National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: http://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on June 24, 2016.
- Bandera A, Gori A, Trabattoni D, et al. Positive Immunomodulatory Effects of Tucaresol in HIV-infected Patients: Results from a Phase I/II Trial after 40 Weeks of Follow-up. Abstract presented at: 10th Conference on Retroviruses and Opportunistic Infections (CROI); February 10-14, 2003; Boston, MA. Abstract 654. Available at: http://www.aegis.org/DisaplayConf/?Abstract=107218. Last accessed on April 23, 2014.
- Gazzola L, Marchetti G, Bandera A, et al. Dynamics of T Cells Homeostasis Induced by Tucaresol. Abstract presented at: 11th Conference on Retroviruses and Opportunistic Infections (CROI); February 8-11, 2004; San Francisco, CA. Abstract 523. Available at: http://www.aegis.org/DisaplayConf/?Abstract=108015. Last accessed on April 23, 2014.
Last Reviewed: June 24, 2016