Drugs

Tucaresol

Tucaresol

Other 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 (discontinued)


(Compound details obtained from ChemIDplus Advanced1 and NIAID Therapeutics Database2)

NOTE: The development of tucaresol for HIV treatment has been discontinued.

NOTE: The development of tucaresol for HIV treatment has been discontinued.

The study of tucaresol as an immune modulator appears to be discontinued. Searching ClinicalTrials.gov for tucaresol trials related to HIV shows no ongoing or planned trials. The last published clinical trial results for tucaresol as an HIV treatment were released in 2005.3

What is an investigational drug?

What is an investigational drug?

An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (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?

What is tucaresol?

Tucaresol is an investigational drug that is categorized as an immune modulator.2 Immune modulators (also called immunomodulators) are substances that help to activate, boost, or restore normal immune function.

HIV infection can damage a person’s immune system over the course of the viral infection. Tucaresol was studied for its ability to help restore or boost the immune systems of people with HIV. 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.4

How are clinical trials of investigational drugs conducted?

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.5

  • 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.5

In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to 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.5

Some clinical trials are categorized as “a” or “b,” such as “Phase Ia” or “Phase IIb.” These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.

In what phase of testing is tucaresol?

In what phase of testing is tucaresol?

Tucaresol has been studied in a Phase II clinical trial.2 The development of tucaresol as an HIV drug appears to have been discontinued.

What are some studies on tucaresol?

What are some studies on tucaresol?

Study Name: Not available
Sponsor: Not available
Phase: I/II
Location: Italy
Participants

  • All participants had HIV.
  • Two groups of participants had never taken HIV medicines before the start of the study. 
  • Two other groups of participants had previously taken HIV medicines before entering the study.
Purpose: The purpose of this study was to look at the safety and immune-modulating effects of tucaresol in different groups of participants. In terms of immune-modulating effects, the study investigated whether tucaresol could increase the number and activity of certain cells of the immune system.4,6,7

For more details on this study, see the Health Professional version.

Other HIV-related clinical trials involving tucaresol have also been completed, including a Phase II study (NCT00343941) that evaluated 2 different doses of tucaresol in participants with viral suppression. (Viral suppression is when ART reduces a person’s viral load to an undetectable level.)8

What side effects might tucaresol cause?

What side effects might tucaresol cause?

In the Phase I/II study discussed under the previous question, the most common side effects in participants taking tucaresol along with their HIV medicines were low-grade fever and other mild constitutional symptoms. (Constitutional symptoms are symptoms affecting the whole body, such as fever and weight loss.)4

If testing of tucaresol continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying tucaresol?

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 ClinicalTrials.gov 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?

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.5

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.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced. Available at: https://chem.sis.nlm.nih.gov/chemidplus/rn/84290-27-7. Last accessed on July 21, 2017.
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on July 21, 2017.
  3. Bulgheroni E, Bandera A, Galli M, Gori A, Rusconi S. Analysis of the env V3 sequences obtained from patients with HIV type 1 infection treated with the immune modulant agent tucaresol. AIDS Res Hum Retroviruses. 2005 Sep;21(9):815-9. Available at: http://www.ncbi.nlm.nih.gov/pubmed/16218807. Last accessed on July 21, 2017.
  4. 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 July 21, 2017.
  5. National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on July 21, 2017.
  6. 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: 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.
  7. Gazzola L, Marchetti G, Bandera A, et al. Dynamics of T Cells Homeostasis Induced by Tucaresol. Abstract presented at: 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.
  8. GlaxoSmithKline. A Phase II multicentre, randomized, double blind, parallel group, placebo controlled pilot study of tucaresol at two dosing levels (25,50 mg) in HIV-1 infected adult subjects with plasma HIV-1 RNA < 50 copies/ml on stable highly active antiretroviral therapy regimen for at least 3 months. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 22, 2006. NLM Identifier: NCT00343941. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00343941. Last accessed on July 21, 2017.

Last Reviewed: July 21, 2017