Drugs

VM-1500

VM-1500

Other Names: Elpida, elpivirine, prodrug of VM-1500A, prodrug of elsulfavirine Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors Organization: Viriom; F. Hoffmann-La Roche Phase of Development: II/III

(Compound details obtained from Viriom website,1,2 CROI 2017 Abstract 452LB,3 and ClinicalTrials.gov4)

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 VM-1500?

What is VM-1500?

VM-1500 (also known as Elpida) is an investigational drug that is being studied for the treatment of HIV infection.2,5

VM-1500 belongs to a class (group) of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs).1,3 NNRTIs attach to and block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NNRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

Studies have shown that VM-1500 appears effective for treating HIV in individuals who have never taken HIV medicines.1,6,7 VM-1500 may also work on certain HIV strains against which other FDA-approved NNRTIs no longer work.1

VM-1500 is designed to be taken once a day by mouth. Other forms of VM-1500, such as a long-lasting injectable form and a sustained-release form, are being studied not only for HIV treatment but also as protection against HIV infection.5

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.8

  • 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.8

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.8 (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 VM-1500?

In what phase of testing is VM-1500?

VM-1500 has been studied in a Phase II/III clinical trial.4

What are some studies on VM-1500?

What are some studies on VM-1500?

Study Name: NCT02485509
Sponsor: Viriom
Phase: Ib/IIa
Location: Thailand
Participants: This study was divided into 2 parts:

  • In Part 1, the participants were adults who were not infected with HIV.
  • In Part 2, the participants were HIV-infected adults who had never taken HIV medicines before the start of the study.
Purpose: The purpose of Part 1 of the study was to evaluate the safety and drug properties of VM-1500 in people who were not infected with HIV. Part 2 was designed to examine the safety, effectiveness, and drug properties of VM-1500 in people with HIV. VM-1500 was compared to placebo in both parts of the study. (A placebo is an inactive drug that is identical in appearance to the active drug being studied.)9

Study Name: NCT02489461
Sponsor: Viriom
Phase: II/III
Location: Russia
Participants:
  • Participants were HIV-infected adults who had never taken HIV medicines before entering the study.
  • Participants had viral load levels of 5,000 copies/mL or more. (Viral load is the amount of HIV in a blood sample.)
  • Participants had CD4 counts greater than 200 cells/mm3 at the start of the study. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)
Purpose: The purpose of this study was to (1) find the most effective dose of VM-1500, and (2) compare the safety and effectiveness of VM-1500 to the FDA-approved HIV medicine efavirenz (brand name: Sustiva).4

For more details on the studies listed above, see the Health Professional version.

What side effects might VM-1500 cause?

What side effects might VM-1500 cause?

In Part 2 of the Phase Ib/IIa study (NCT02485509) discussed under the previous question, reported side effects included mild dry mouth, mild headache, and excessive urination.6,9

In the first part the Phase II/III trial (NCT02489461), side effects caused by the study drugs occurred more often in participants taking efavirenz than in participants taking VM-1500. Of note, brain-related side effects that commonly occurred in participants taking VM-1500 included headache, unusual dreams, dizziness, problems with sleep, drowsiness, depression and nightmares. All of these side effects, plus insomnia and memory problems, occurred in the efavirenz group.4,10

In the second part of the Phase II/III trial, the most common side effects reported by participants taking VM-1500 or efavirenz were headache, dizziness, and sleep disorders. Abnormal dreams, skin rash, and itchiness occurred only in participants taking efavirenz. One participant receiving VM-1500 and 7 participants receiving efavirenz dropped out of the study because of a side effect.7

Because VM-1500 is still being studied, information on possible side effects of the drug is not complete. As testing of VM-1500 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying VM-1500?

Where can I get more information about clinical trials studying VM-1500?

More information about VM-1500–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.8

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. Viriom, Inc.: Press Release, dated November 19, 2013. Viriom expands global licensing agreement with Roche for innovative HIV treatment compound development. Available at: https://www.viriom.com/press-releases/2016/12/13/viriom-expands-global-licensing-agreement-with-roche-for-innovative-hiv-treatment-compound-development. Last accessed on May 9, 2017.
  2. Viriom, Inc.: Press Release, dated December 14, 2015. Viriom, Inc. announces the publication of results from an efficacy and safety study with elsulfavirine in the journal “National Scientific Society of Infectious Disease Specialists.” Available at: https://www.viriom.com/press-releases/2016/12/13/viriom-inc-announces-the-publication-of-results-from-an-efficacy-and-safety-study-with-elpida-in-the-journal-national-scientific-society-of-infectious-disease-specialists. Last accessed on May 9, 2017.
  3. Murphy R, Kravchenko AV, Orlova-Morozova E, et al. Elsulfavirine as compared to efavirenz in combination with TDF/FTC: 48-week study. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, Washington. Abstract 452LB. Available at: http://www.croiconference.org/sessions/elsulfavirine-compared-efavirenz-combination-tdfftc-48-week-study. Last accessed on May 9, 2017.
  4. Viriom. International, multicenter, randomized, partially blind clinical study to evaluate efficacy, safety and selection of the optimal dose for VM-1500 in comparison to efavirenz in combination with two NRTIs in treatment-naive, HIV-1 infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 18, 2015. NLM Identifier: NCT02489461. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02489461. Last accessed on May 9, 2017.
  5. Viriom, Inc. website. Pipeline. Available at: https://www.viriom.com/pipeline/. Last accessed on May 9, 2017.
  6. Ratanasuwan W, Werarak P, Murphy RL, Bichko V. A randomized, placebo-controlled, double-blind study of VM-1500 in HIV-naive patients. Abstract presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2014; Boston, Massachusetts. Abstract 544LB. Available at: http://www.croiconference.org/sites/default/files/abstracts/544LB.pdf. Last accessed on May 9, 2017.
  7. Murphy RL, Kravchenko AV, Orlova-Morozova EA, et al. Elsulfavirine as compared to efavirenz in combination with TDF/FTC: 48-week study. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, Washington. Poster 452LB. Available at: http://www.croiconference.org/sites/default/files/posters-2017/452LB_Murphy.pdf. Last accessed on May 9, 2017.
  8. National Institutes of Health (NIH). NIH clinical research trials and you. Available at: http://nih.gov/health/clinicaltrials/index.htm. Last accessed on May 9, 2017.
  9. Viriom. Phase Ib/IIa, single-centre, placebo-controlled randomized study of safety and pharmacokinetics in healthy volunteers and safety, tolerability and antiviral activity of VM-1500 in patients with human immunodeficiency virus-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 18, 2015. NLM Identifier: NCT02485509. Available at: https://clinicaltrials.gov/ct2/show/NCT02485509. Last accessed on May 9, 2017.
  10. Kravchenko AV, Orlova-Morozova EA, Nagimova FI, et al. Safety and antiviral effect of Elpida (VM-1500), a novel NNRTI (+Truvada) in treatment-naive HIV-1 infected patients. Poster presented at: European AIDS Conference (EAC); October 21-24, 2015; Barcelona, Spain. Poster PE7/4. Available at: http://rusnanonet.ru/download/documents/barcelona2015.pdf. Last accessed on May 9, 2017.

Last Reviewed: May 9, 2017