Drugs

Tat Oyi

Tat Oyi

Drug Class: Therapeutic Vaccines Organization: Biosantech Phase of Development: I/IIa

(Compound details obtained from Treatment Action Group website,1 Biosantech website,2 and Retrovirology article3)

What is Tat Oyi?

What is Tat Oyi?

Tat Oyi is an investigational vaccine that is being studied as a possible strategy to treat people living with HIV.4 Tat Oyi belongs to a group of HIV vaccines called therapeutic HIV vaccines.

To learn how investigational vaccines and drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

How do therapeutic HIV vaccines work?

How do therapeutic HIV vaccines work?

A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person living with HIV.5 Therapeutic vaccines may be able to reduce the amount of HIV in the body and help keep HIV at undetectable levels without the need for regular antiretroviral therapy.5 To learn more, read the AIDSinfo What is a Therapeutic HIV Vaccine? fact sheet.

There are several types of therapeutic vaccines currently being studied to treat HIV. The Tat Oyi vaccine contains a specific HIV protein that helps the body produce an immune response that can fight the virus.3,6

Which clinical trials are studying Tat Oyi?

Which clinical trials are studying Tat Oyi?

Study Names: EVATAT trial; NCT01793818
Phase: I/IIa
Status: This study has been completed.
Location: France
Purpose: The purpose of this study was to evaluate both the safety of the Tat Oyi vaccine and the vaccine’s ability to control viral load levels during a planned break from HIV medicines (called a treatment interruption).1,3,7

For more details on the study mentioned above, see the Health Professional version of this drug summary.

What side effects might Tat Oyi cause?

What side effects might Tat Oyi cause?

One goal of HIV research is to identify new drugs that have fewer side effects. In the EVATAT trial (NCT01793818) discussed under the previous question, five out of 46 study participants experienced a serious side effect. Of those five participants, only one had a side effect (facial pain) that was possibly related to the Tat Oyi vaccine. This side effect occurred 11 months after the participant received the vaccine and lasted for 1 week.3 Some participants in the study also reported pain at the site of the injection.6

Because Tat Oyi is still being studied, information on possible side effects of the vaccine is not complete. As testing of Tat Oyi continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying Tat Oyi?

Where can I get more information about clinical trials studying Tat Oyi?

More information about Tat Oyi-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.

Some clinical trials may be looking for volunteer participants. 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. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed May 3, 2019.
  2. Biosantech website. Research program Tat. http://biosantech-vih.fr/programme-de-recherche-tat/?lang=en. Accessed May 3, 2019.
  3. Loret EP, Darque A, Jouve E, et al. Intradermal injection of a Tat Oyi-based therapeutic HIV vaccine reduces of 1.5 log copies/mL the HIV RNA rebound median and no HIV DNA rebound following cART interruption in a Phase I/II randomized controlled clinical trial. Retrovirology. 2016;13. doi:10.1186/s12977-016-0251-3
  4. Frick M, Gaudino A, Harrington M, et al. Treatment Action Group. 2017 pipeline report. http://www.pipelinereport.org/sites/default/files/2017%20Pipeline%20Report%20Final.pdf. Published July 2017. Accessed May 3, 2019.
  5. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed May 3, 2019.
  6. Escaich S. Tat Oyi-based candidate therapeutic vaccine: a successful Phase 1 clinical trial in HIV-1 infected patients. Abstract presented at: International Conference on Retroviruses and Novel Drugs; June 8-9, 2015; Chicago, IL. https://retrovirus.conferenceseries.com/abstract/2015/tat-oyi-based-candidate-therapeutic-vaccine-a-successful-phase-1-clinical-trial-in-hiv-1-infected-patients. Accessed May 3, 2019.
  7. Biosantech. Evaluation on seropositive patients of a synthetic vaccine targeting the HIV Tat protein. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 14, 2013. NLM Identifier: NCT01793818. https://clinicaltrials.gov/ct2/show/NCT01793818. Accessed May 3, 2019.

Last Reviewed: May 3, 2019

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