Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App 
Professionals >> Visit The Body PROThe Body en Espanol
  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

Information

An Overview of Ibalizumab

March 8, 2017

 1  |  2  |  Next > 

Other Names: Hu5A8, TMB-355, TNX-355
Drug Class: Entry Inhibitor
Registry Number: 680188-33-4 (CAS)
Chemical Name: Immunoglobulin G4, anti-(human CD4 (antigen)) (human-mouse monoclonal 5A8 γ4-chain), disulfide with human-mouse monoclonal 5A8 κ-chain, dimer
Company: TaiMed Biologics
Phase of Development: III

(Compound details obtained from ChemIDplus Advanced1 and NIAID Therapeutics Database2)


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 Ibalizumab?

Ibalizumab is an investigational drug that is being studied for the treatment and prevention of HIV infection.3

Ibalizumab belongs to a class (group) of HIV drugs called entry and fusion inhibitors.2 Entry and fusion inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.

Ibalizumab works by attaching to a protein on the surface of the immune cells. The protein is called the CD4 receptor. When ibalizumab attaches to the CD4 receptor, HIV cannot attach to, enter, or infect the cell.4


Advertisement

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.5

  • 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.5

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.5 (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 Ibalizumab?

Ibalizumab is currently being studied in a Phase III clinical trial.2


What Are Some Studies on Ibalizumab?

Study Name: NCT00089700
Sponsor: Tanox
Phase: IIa
Location: United States, Canada, and Puerto Rico
Participants:

  • Participants were HIV-infected adults who had been on antiretroviral therapy (ART) for at least 6 months before starting the study. (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from multiplying.)
  • At some point during their ART, participants had taken a nucleoside reverse transcriptase inhibitor (NRTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and a protease inhibitor (PI).
  • Participants were either (1) on an ART regimen and experiencing treatment failure at the start of the study or (2) had experienced treatment failure within the 8 weeks before entering the study. (Treatment failure is when an ART regimen is unable to control HIV infection.)
Purpose: The purpose of this study was to determine the safety and effectiveness of ibalizumab when compared to a placebo.6,7


Study Names: TMB-202; NCT00784147
Sponsor: TaiMed Biologics Inc.
Phase: IIb
Location: United States and Puerto Rico
Participants
  • Participants were HIV-infected adults who had been on ART before starting the study. Participants either (1) were on ART for at least 8 weeks before entering the study or (2) had treatment failure within the 8 weeks before entering the study and were off therapy.
  • Participants' HIV had not responded to at least 1 HIV medicine from each of the following 3 drug classes: NRTIs, NNRTIs, and PIs. 
Purpose: The purpose of this study was to look at the safety, tolerability, and antiviral activity of 2 different dosing regimens of ibalizumab.8,9 
Note: Participants who had a successful antiviral response to ibalizumab in Study TMB-202 could choose to extend their treatment regimen of ibalizumab plus an optimized background regimen beyond 24 weeks under a separate study protocol (NCT01056393). (An optimized background regimen is a combination of drugs that are not being studied as the investigational drug in the clinical trial but are given to help control a participant's HIV infection. The drugs in an optimized background regimen are chosen on the basis of a person's resistance test results and treatment history.)10


Study Names: TMB-301; NCT02475629
Sponsor: TaiMed Biologics Inc.
Phase: III
Location: United States, Puerto Rico, and Taiwan
Participants
  • Participants were HIV-infected adults whose HIV had not responded to at least 1 HIV medicine from each of 3 HIV drug classes.
  • Participants had a type of HIV that could be treated with at least 1 additional ARV drug other than ibalizumab.
  • Participants had a viral load (the amount of HIV in a blood sample) greater than 1,000 copies/mL.
  • All participants had a history of at least 6 months on ART. Participants either (1) were on an unchanged ART regimen for at least 8 weeks before study entry and were experiencing treatment failure or (2) had experienced treatment failure within the 8 weeks before entering the study and were off therapy at the time of study entry.
Purpose: The purpose of this study was to look at the safety and effectiveness of ibalizumab.11


Study Names: TMB-311; NCT02707861
Sponsor: TaiMed Biologics Inc.
Phase: III
Location: United States and Puerto Rico
Participants: This study involves 2 groups of participants:
  • One group has already completed a previous ibalizumab clinical trial.
  • The other group includes HIV-infected adults who have taken ART before but have never taken ibalizumab before. Participants in this group have a viral load greater than 1,000 copies/mL. They were on ART for at least 6 months and are currently on a failing ART regimen or have had treatment failure in the past and are off ART now.
  • Participants have a type of HIV that can be treated by at least 1 additional antiretroviral drug other than ibalizumab.

Purpose: The purpose of this study is to investigate the safety and tolerability of ibalizumab. The study will also provide access to ibalizumab for people with multidrug-resistant HIV who have previously taken ibalizumab.12
* This study is currently recruiting participants.


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

A subcutaneous (SC) injection form of ibalizumab has been studied in a Phase I trial (NCT01292174). (An SC injection is placed under the skin.) This study looked at the safety and drug properties of ibalizumab given by SC injection to at-risk, HIV-uninfected adults. Results from the study support further research of SC ibalizumab for HIV treatment or as prevention medicine.13,14 An intramuscular (IM) form of ibalizumab has also been studied in a Phase I/II trial. The study looked at the drug properties, safety, and effectiveness of IM ibalizumab in HIV-infected participants.15 


What Side Effects Might Ibalizumab Cause?

In the Phase IIb study (NCT00784147) discussed under the previous question, the most common side effects reported were the following: rash, diarrhea, headache, and nausea. Most side effects were considered mild to moderate.8,16

During the first 2 weeks of the Phase III study (NCT02475629), side effects included dizziness, weakness, fatigue, nausea, vomiting, and rash. At the end of the study (Week 24), researchers reported that most of the side effects were mild to moderate in intensity. One participant had immune reconstitution inflammatory syndrome (IRIS), which was related to ibalizumab and caused the participant to stop the study early.11,17,18

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


Where Can I Get More Information About Clinical Trials Studying Ibalizumab?

More information about ibalizumab-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?

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.5

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.

 1  |  2  |  Next > 


Related Stories

More on HIV Medications
More on Entry Inhibitors in Development


  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

 

Advertisement