Drug information

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Pronounce:
Other Names:
GSK'254
Drug Class:
Maturation Inhibitors
Organization:
ViiV Healthcare
Phase of Development:

GSK3640254 is in Phase 2b development for HIV treatment.

(Compound details obtained from NIAID Therapeutics Database1 and ClinicalTrials.gov2)

 
What is GSK3640254?What is GSK3640254?

What is GSK3640254?

GSK3640254 is an investigational drug that is being studied to treat HIV infection.1

GSK3640254 belongs to a group of HIV drugs called maturation inhibitors.1 Maturation inhibitors work during the last stage of the HIV life cycle and interfere with the formation of mature, infectious virus. Specifically, maturation inhibitors block a long HIV protein chain called Gag from being broken up into smaller parts that are needed to create mature virus.3 This prevents HIV from multiplying, and can reduce the amount of HIV in the body.

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

Select clinical trials of GSK3640254Select clinical trials of GSK3640254

Select clinical trials of GSK3640254

Study Name: NCT03784079
Phase: 2a
Status: This study has been completed.
Locations: Multiple countries, including United States
Purpose: The purpose of this study was to evaluate the antiviral activity, safety, and pharmacokinetics of GSK3640254 in adults who have never taken HIV medicines.4,5

Study Name: NCT04493216
Phase: 2b
Status: This study is currently recruiting participants.
Locations: Multiple countries, including United States
Purpose: The purpose of this study is to evaluate the safety and efficacy of GSK3640254 (given at three different doses) compared to dolutegravir (brand name: Tivicay), each given in combination with abacavir/lamivudine (brand name: Epzicom) or emtricitabine/tenofovir alafenamide (brand name: Descovy) in adults who have never taken HIV medicines.2

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

What side effects might GSK3640254 cause?What side effects might GSK3640254 cause?

What side effects might GSK3640254 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. In the NCT03784079 study discussed under the previous question, 22 out of 30 participants who received GSK3640254 expereienced a side effect. The most common side effect was headache, which occurred in four participants. Side effects related to GSK3640254 treatment were all mild to moderate in intensity and occurred in nine participants. Drug-related diarrhea occurred in three participants, and drug-related abdominal pain and vomiting occurred in two participants each.5

Because GSK3640254 is still being studied, information on possible side effects of the drug is not complete. As testing of GSK3640254 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying GSK3640254?Where can I get more information about clinical trials studying GSK3640254?

Where can I get more information about clinical trials studying GSK3640254?

More information about GSK3640254-related research studies is available from ClinicalTrials.gov.

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.

ReferencesReferences

References

  1. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed April 29, 2021
  2. ViiV Healthcare. A Phase IIb, randomized, partially blind, active controlled, dose-range finding study of GSK3640254 compared to a reference arm of dolutegravir, each in combination with nucleoside reverse transcriptase inhibitors, in HIV-1 infected antiretroviral treatment-naive adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on July 10, 2020. NLM Identifier: NCT04493216. https://clinicaltrials.gov/ct2/show/NCT04493216. Accessed April 29, 2021
  3. Pene Dumitrescu, T. et al. A Phase I evaluation of the pharmacokinetics and tolerability of the HIV-1 maturation inhibitor GSK3640254 and tenofovir alafenamide/emtricitabine in healthy participants. Antimicrob Agents Chemother AAC.02173-20, aac;AAC.02173-20v1 (2021) doi:10.1128/AAC.02173-20.
  4. ViiV Healthcare. A randomized, double-blind (sponsor-unblinded), placebo-controlled, adaptive trial to investigate the antiviral effect, safety, tolerability and pharmacokinetics of GSK3640254 in HIV-1 infected treatment-naïve adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 19, 2018. NLM Identifier: NCT03784079. https://clinicaltrials.gov/ct2/show/NCT03784079. Accessed April 29, 2021
  5. Spinner C, Felizarta F, Rizzardini G, et al. Phase IIA proof-of-concept trial of next-generation maturation inhibitor GSK3640254. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 6-10, 2021; Virtual. http://www.croiwebcasts.org/console/player/48166?mediaType=slideVideo&. Accessed April 29, 2021
 

Last Reviewed: April 29, 2021