Drugs

TUTI-16

TUTI-16

Other Names: Thymon Universal Tat Immunogen Drug Class: Therapeutic Vaccines Organization: Thymon, LLC Phase of Development: TUTI-16 is in Phase I/II development as a therapeutic HIV vaccine.

(Compound details obtained from Treatment Action Group website1 and ClinicalTrials.gov2)

What is TUTI-16?

What is TUTI-16?

TUTI-16 is an investigational vaccine that has been studied as a possible strategy to treat people living with HIV.1 TUTI-16 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.3 Therapeutic vaccines work by strengthening the immune system to recognize and eliminate HIV from the body. 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. TUTI-16 is made up of HIV peptides, which are pieces of HIV proteins. The HIV peptides in the TUTI-16 vaccine are used to help the body generate an immune response against HIV.2

Which clinical trials are studying TUTI-16?

Which clinical trials are studying TUTI-16?

Study Names: THYMON-08001; NCT00848211
Phase: I/IIa
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of TUTI-16 and its ability to produce an immune response in the body. In addition, this study assessed whether TUTI-16 could reduce viral load levels and sustain CD4 counts in individuals with HIV who were not receiving antiretroviral therapy (ART).4,5

Study Names: THYMON-10001; NCT01144026
Phase: I/IIa
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of TUTI-16 and its ability to produce an immune response in both people with HIV and people without HIV who had undetectable viral load levels on ART.2,4

Study Names: THYMON-11001; NCT01335191
Phase: I/II
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of TUTI-16 and its ability to produce an immune response in the body. This study also assessed whether TUTI-16 could control viral load during a treatment interruption of ART.6,7 A treatment interruption of ART is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant’s viral load during a clinical trial.

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

What side effects might TUTI-16 cause?

What side effects might TUTI-16 cause?

One goal of HIV research is to identify new drugs that have fewer side effects.  The following side effects were observed in the studies of TUTI-16 listed above.

THYMON-08001 (NCT00848211):
Among the participants who completed this Phase I/IIa study, no serious side effects were reported. Some participants experienced injection-related reactions of redness, tenderness, pain, or hardening of the skin at or near the injection site. Other injection-related side effects included fatigue/weakness and nausea. Most of these injection-related side effects were mild and temporary, and only 1 participant reported moderate fatigue.4

THYMON-10001 (NCT01144026):
In this Phase I/IIa study, TUTI-16 was evaluated in participants with HIV and healthy participants without HIV. Among the healthy participants, 4 had side effects that lasted for several days: 1 person experienced mild injection site redness and tenderness and 3 people reported flu-like symptoms. Among the participants with HIV, 3 had mild side effects: 1 person experienced injection site redness and 2 had temporary elevated liver enzymes.

THYMON-11001 (NCT01335191):
In this Phase I/II study, no serious side effects were reported. Eighty-one percent of participants in the TUTI-16 group and 36% of participants in the placebo group experienced a side effect that was possibly injection-related. The most common injection-related reactions included pain at the injection site, flu-like symptoms, chills, dizziness, and muscle aches. All side effects were mild, except for 1 which was moderate in severity.7 

Information on possible side effects of TUTI-16 is not complete. As testing of TUTI-16 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying TUTI-16?

Where can I get more information about clinical trials studying TUTI-16?

More information about TUTI-16-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 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.
  2.  Thymon, LLC. Phase I/IIA clinical study of TUTI-16 in HIV-1 infected and uninfected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 12, 2010. NLM Identifier: NCT01144026. https://clinicaltrials.gov/ct2/show/NCT01144026. Accessed August 20, 2018.
  3. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines.
  4. Goldstein G, Chicca 2nd J. Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naïve and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects. Human Vaccines & Immunotherapeutics. 2012;8(4):479-485. doi:10.4161/hv.19184
  5. Thymon, LLC. Phase I/IIA clinical study of TUTI-16 in asymptomatic HIV-1 infected subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 13, 2009. NLM Identifier: NCT00848211. https://clinicaltrials.gov/ct2/show/NCT00848211. Accessed August 20, 2018.
  6. Thymon, LLC. Clinical study of TUTI-16 in asymptomatic, HIV-1 infected subjects effectively controlled by antiretroviral therapy and the effects on viral load during a structured treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 12, 2011. NLM Identifier: NCT01335191. https://clinicaltrials.gov/ct2/show/NCT01335191. Accessed August 20, 2018.
  7. Goldstein G, Damiano E, Donikyan M, Pasha M, Beckwith E, Chicca J. HIV-1 Tat B-cell epitope vaccination was ineffectual in preventing viral rebound after ART cessation. Hum Vaccin Immunother. 2012;8(10):1425-1430. doi:10.4161/hv.21616

Last Reviewed: August 27, 2018