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Information

An Overview of PRO-140

July 14, 2017

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Other Names: PA14
Drug Class: Entry Inhibitor
Registry Number: 674782-26-4 (CAS)
Organization: CytoDyn, Inc.
Phase of Development: IIb/III

(Compound details obtained from ChemIDplus Advanced1, NIAID Therapeutics Database2, and CytoDyn website3)


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 PRO-140?

PRO-140 is an investigational drug that is being studied for the treatment of HIV infection.

PRO-140 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.

PRO-140 works by attaching to a protein on the surface of the immune cells. The protein is called the CCR5 co-receptor. When PRO-140 attaches to the CCR5 co-receptor, certain strains of HIV -- called R5-tropic virus -- cannot attach to, enter, or infect the cell.5

Research may prove that PRO-140 is a safe and effective option for treating people with R5-tropic virus, including those for whom other entry and fusion inhibitors, such as maraviroc (brand name: Selzentry), are not working.6


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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.7

  • 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.7

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.

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 PRO-140?

PRO-140 is currently being studied in Phase IIb/III clinical trials.4,8


What Are Some Studies on PRO-140?

Study Name: NCT00642707
Sponsor: CytoDyn, Inc.
Phase: IIa
Location: United States
Participants:

  • Participants were HIV-infected adults with R5-tropic HIV. If participants had been on antiretroviral therapy (ART) before, they were required to be off ART for at least 12 weeks before starting the study. (ART is the recommended treatment for HIV infection and involves using a combination of different antiretroviral [ARV] drugs to prevent HIV from replicating.)
  • Participants had viral load levels (the amount of HIV in a blood sample) of at least 5,000 copies/mL.
  • Participants had CD4 counts of at least 300 cells/mm3, and their lowest ever CD4 count was above 250 cells/mm3. (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 look at the effectiveness, safety, and drug properties of different doses of PRO-140 and compare PRO-140 to a placebo. (A placebo is an inactive drug that is identical in appearance to the active drug being studied.) PRO-140 was given without any other HIV medicines (also known as monotherapy) and by subcutaneous infusion. (A subcutaneous infusion is an injection placed under the skin to deliver a drug or other fluids over a period of time.)9,10

Study Names: (1) PRO 140_CD 01; NCT02175680 and (2) PRO 140_CD 01-Extension; NCT02355184
Sponsor: CytoDyn, Inc.
Phase: IIb
Location: United States
Participants:

  • Participants were HIV-infected adults with R5-tropic HIV.
  • During the 12 months before starting the main study (PRO 140_CD 01), participants had been on ART and had had undetectable viral loads. In the 4 weeks prior to the main study, participants did not change their ART regimens. Also, participants had at least 2 other possible ART regimens that they could consider taking.
  • For the main study, participants had viral load levels that were less than 100 copies/mL. Their CD4 counts were greater than 350 cells/mm3, and their lowest ever CD4 count was above 200 cells/mm3.
  • Participants who completed 12 weeks of treatment in the main study without having virologic failure were allowed to enroll in the PRO 140_CD 01-Extension study, which is currently ongoing but not recruiting participants. (Virologic failure is when ART cannot suppress a person's viral load to less than 200 cells/mL.) 

Purpose: The purpose of this study and its extension study is to evaluate whether certain individuals who already have undetectable viral loads might be able to take a planned temporary break from their daily ART by using PRO-140 as a treatment substitution to maintain viral suppression.11-13

Study Names: (1) PRO 140_CD 02; NCT02483078 and (2) PRO 140_CD 02 Extension; NCT02990858
Sponsor: CytoDyn, Inc.
Phase: IIb/III
Location: United States and Puerto Rico
Participants:

PRO 140_CD 02:

  • Participants are HIV-infected adults with R5-tropic HIV.
  • Participants have been on their current ART regimens for at least 3 months. However, these ART regimens are failing, which means the participants' HIV infections are not being controlled with their current ART regimens.
  • Participants have developed drug resistance and have limited treatment options.
  • Participants have viral load levels of at least 400 copies/mL at the start of the study and have had detectable viral load levels of more than 50 copies/mL during the 3 months before the study started.
PRO 140_CD 02 Extension:
  • Participants have successfully completed 24 weeks of treatment in the PRO 140_CD 02 trial and need to continue taking PRO-140 to maintain viral suppression.

Purpose: The purpose of this study is to look at the safety and effectiveness of using PRO-140 with a failing ART regimen for 1 week and then using PRO-140 with an optimized ART regimen for 24 weeks. (An optimized ART regimen is a combination of drugs chosen on the basis of a person's resistance test results and treatment history.) PRO 140_CD 02 Extension is designed to provide eligible participants with continued access to PRO-140.4,14

* PRO 140_CD 02 is currently recruiting participants.

Study Names: PRO 140_CD03; NCT02859961
Sponsor: CytoDyn, Inc.
Phase: IIb/III
Location: United States
Participants:

  • Participants are adults with CCR5-tropic HIV. 
  • Participants have been on ART for the past 24 weeks, have had no changes to their ART regimen in the 4 weeks before the study, and have at least 2 possible ART drugs to consider.
  • Participants have viral load levels of less than 50 copies/mL at the start of the study. Participants have had CD4 counts greater than 350 cells/mmin the 24 weeks before the study and at the start of the study. A participant's lowest ever CD4 count while on ART has been above 200 cells/mm3.

Purpose: The purpose of this study is to evaluate the safety and effectiveness of PRO-140 monotherapy for the maintenance of viral suppression over 48 weeks.8

* This study is currently recruiting participants.

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

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More on Entry Inhibitors in Development


  
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