Drugs

LC002

LC002

Other Names: DermaVir, DermaVir patch Drug Class: Therapeutic Vaccines Organization: Genetic Immunity Phase of Development: LC002 is in Phase 3 development as a therapeutic HIV vaccine.

(Compound details obtained from Research Toward a Cure website1 and Genetic Immunity website2)

What is LC002?

What is LC002?

LC002 is an investigational vaccine that is being studied as a possible strategy to treat people living with HIV. LC002 belongs to a group of HIV vaccines called therapeutic HIV vaccines.1

To learn how investigational 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.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 (ART). 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. LC002 is a DNA vaccine developed using HIV’s genetic information. The aim of the vaccine is to produce an immune response against HIV in the body.4

Which clinical trials are studying LC002?

Which clinical trials are studying LC002?

Study Names: ACTG 5176; A5176; NCT00270205
Phase: 1/2
Status: This study has been completed.
Location: United States
Purpose: The purpose of this study was to evaluate the safety of LC002 and its ability to produce an immune response in people with chronic HIV infection.5,6

Study Names: GIEU006; NCT00711230
Phase: 2
Status: This study has been completed.
Location: Germany
Purpose: The purpose of this study was to evaluate the safety of LC002 and its ability to produce an immune response in people with HIV who have never taken HIV medicines. This study also looked at LC002’s ability to reduce viral load levels.1,7

Study Name: GIRU001
Phase: 3
Status: This study is ongoing.
Location: Russia
Purpose: The purpose of this study is to evaluate the ability of LC002 to produce an immune response in people with HIV when LC002 is used in combination with ART. Researchers will also evaluate whether LC002 can control participants’ viral load levels during a structured treatment interruption of ART.2

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

Additional clinical trials evaluating LC002 have also been completed, including a Phase 2 trial (NCT00918840) that looked at LC002’s ability to produce an immune response in the body and its impact on viral load levels during a structured interruption of ART.8

What side effects might LC002 cause?

What side effects might LC002 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of LC002 listed above.

ACTG 5176; NCT00270205:

In this study, the most common side effects reported by participants were general body complaints, such as aches, pain, discomfort, fatigue, or fever. Some participants had skin reactions, such as itchiness and rash, as well as abnormal blood tests. All LC002-related side effects that occurred during the trial were mild or moderate in severity. None of the participants stopped or changed their treatment because of a side effect.5

GIEU006; NCT00711230:

All side effects reported by participants in this study were considered mild or moderate. None of the participants stopped treatment because of side effects. Only one side effect (limb pain under stress) was possibly related to LC002, but this side effect went away before the end of the study.9

Because LC002 is still being studied, information on possible side effects of the drug is not complete. As testing of LC002 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying LC002?

Where can I get more information about clinical trials studying LC002?

More information about LC002-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 June 24, 2019.
  2. Genetic Immunity website. DermaVir. https://www.geneticimmunity.com/dermavir.html. Accessed June 24, 2019.
  3. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed June 24, 2019.
  4. Genetic Immunity website. Our immune-therapy technology platform. https://www.geneticimmunity.com/products.html. Accessed June 24, 2019.
  5. Rodriguez B, Asmuth DM, Matining RM, et al. Safety, tolerability and immunogenicity of repeated doses of DermaVir, a candidate therapeutic HIV vaccine, in HIV infected patients receiving combination antiretroviral therapy. Results of the ACTG 5176 trial. J Acquir Immune Defic Syndr. 2013;64(4):351-359. doi:10.1097/QAI.0b013e3182a99590
  6. National Institute of Allergy and Infectious Diseases (NIAID). A Phase I/II, randomized, double-blind study to evaluate the safety, tolerability, and immunogenicity of LC002, a DermaVir vaccine, in HIV-1-infected subjects currently under treatment with highly active antiretroviral therapy (HAART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 21, 2005. NLM Identifier: NCT00270205. https://www.clinicaltrials.gov/ct2/show/NCT00270205. Accessed June 24, 2019.
  7. Genetic Immunity. A Phase II randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, immunogenicity, and antiretroviral activity of DermaVir patch (LC002) in treatment-naïve HIV-1-infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 4, 2008. NLM Identifier: NCT00711230. https://www.clinicaltrials.gov/ct2/show/NCT00711230. Accessed June 24, 2019.
  8. Genetic Immunity. Antiretroviral-sparing concept: an exploratory Phase II, randomized, single blind placebo-controlled study to investigate the effect of therapeutic immunization on the quantity of HIV-specific T cell precursors during highly active antiretroviral therapy followed by analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 8, 2009. NLM Identifier: NCT00918840. https://www.clinicaltrials.gov/ct2/show/NCT00918840. Accessed June 24, 2019.
  9. van Lunzen J, Pollard R, Stellbrink H-J, et al. DermaVir for initial treatment of HIV-infected subjects demonstrates preliminary safety, immunogenicity and HIV-RNA reduction versus placebo immunization. Poster presented at: International AIDS Conference; July 18-23, 2010; Vienna, Austria. https://www.researchgate.net/publication/264848719_DermaVir_for_initial_treatment_of_HIV-infected_subjects_demonstrates_preliminary_safety_immunogenicity_and_HIV-RNA_reduction_versus_placebo_immunization_A-240-0111-_12561. Accessed June 24, 2019.

Last Reviewed: June 24, 2019

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