Drugs

AMD-070

AMD-070

Other Names: AMD-11070 Drug Class: Entry Inhibitor Molecular Formula: C21 H27 N5 Registry Number: 558447-26-0 (CAS) Chemical Name: N'-(1H-benzimidazol-2-ylmethyl)-N'-[(8S)-5,6,7,8-tetrahydroquinolin-8-yl]butane-1,4-diamine Chemical Class: Benzimidazoles Organization: Genzyme Corporation Phase of Development: I/II (discontinued)

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

NOTE: The development of AMD-070 for HIV treatment has been discontinued.

NOTE: The development of AMD-070 for HIV treatment has been discontinued.

The study of AMD-070 as an HIV medicine appears to be discontinued. Searching ClinicalTrials.gov for AMD-070 trials related to HIV currently shows no ongoing or planned trials. The last published clinical trial results for AMD-070 as an HIV treatment were released in 2009.3

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 AMD-070?

What is AMD-070?

AMD-070 is an investigational drug that was studied for the treatment of HIV infection.

AMD-070 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.

AMD-070 works by attaching to a protein on the surface of the immune cells. The protein is called the CXCR4 co-receptor. When AMD-070 attaches to the CXCR4 co-receptor, certain strains of HIV—called R4-tropic virus—cannot attach to, enter, or infect the cell.4

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.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 AMD-070?

In what phase of testing is AMD-070?

AMD-070 has been studied in Phase I/II clinical trials.2 The development of AMD-070 as an HIV drug appears to have been discontinued.

What are some studies on AMD-070?

What are some studies on AMD-070?

Study Names: X4 Antagonist Concept Trial (XACT); NCT00361101
Sponsor: Genzyme, a Sanofi Company
Phase: I/II
Location: United States and United Kingdom
Participants:

  • The participants were HIV-infected adults who had HIV that used the CXCR4 co-receptor (either X4- or dual-tropic virus). (X4-tropic virus is HIV that uses CXCR4 as a co-receptor, while dual-tropic virus is HIV that uses either CCR5 or CXCR4 as a co-receptor.)
  • Some of the participants had never taken HIV medicines before entering the study, and others had taken HIV medicines previously. Participants who had previously taken HIV medicines were required to be off HIV medicines for at least 14 days before starting AMD-070.
  • Participants had viral load levels of at least 5,000 copies/mL. (Viral load is the amount of HIV in a blood sample.)
  • Participants had CD4 cell counts of less than 200 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 safety and effectiveness of AMD-070 when taken without any other HIV medicines.3,6,7

Study Names: ACTG A5210; NCT00089466
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase: Ib/IIa
Location: United States
Participants:

  • The participants were HIV-infected adults who had HIV that used the CXCR4 co-receptor (either X4- or dual-tropic virus).
  • Some of the participants had never taken HIV medicines before entering the study, and others had taken HIV medicines previously. Participants who had previously taken HIV medicines were required to be off HIV medicines for at least 14 days before starting AMD-070.
  • Participants had viral load levels of at least 5,000 copies/mL within 60 days of the start of the study.
Purpose: The purpose of this study was to look at the safety and effectiveness of AMD-070 when taken without any other HIV medicines.8

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

What side effects might AMD-070 cause?

What side effects might AMD-070 cause?

In the XACT study (NCT00361101) discussed under the previous question, the following side effects were reported: mild gastrointestinal symptoms, including diarrhea and gas (flatulence); headache; and dizziness.3

If testing of AMD-070 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying AMD-070?

Where can I get more information about clinical trials studying AMD-070?

More information about AMD-070–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.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.

References

References

  1. United States National Library of Medicine. ChemIDplus Advanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/rn/558447-26-0. Last accessed on January 24, 2017.
  2. National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. Available at: http://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Last accessed on January 24, 2017.
  3. Moyle G, DeJesus E, Boffito M, et al. Proof of Activity with AMD11070, an Orally Bioavailable Inhibitor of CXCR4-Tropic HIV Type 1. Clin Infect Dis. 2009 Mar 15;48(6):798-805. Available at: http://cid.oxfordjournals.org/content/48/6/798.long. Last accessed on January 24, 2017.
  4. Wong R, Bodart V, Metz M, Labrecque J, Bridger G, Fricker S. Understanding the Interactions Between CXCR4 and AMD11070, a First-in-Class Small Molecule Antagonist of the HIV Coreceptor. Poster presented at: 14th Conference on Retroviruses and Opportunistic Infections (CROI); February 25-28, 2007; Los Angeles, CA. Poster 495. Available at: https://www.researchgate.net/publication/267229718_Understanding_the_Interactions_Between_CXCR4_and_AMD11070_a_First-in-Class_Small_Molecule_Antagonist_of_the_HIV_Coreceptor. Last accessed on January 24, 2017.
  5. National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: http://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on January 24, 20176.
  6. Genzyme, a Sanofi Company. Multicenter, Dose-finding Safety and Activity Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 3, 2006. NLM Identifier: NCT00361101. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00361101. Last accessed on January 24, 2017.
  7. Cao YJ, Flexner CW, Dunaway S, et al. Effect of Low-Dose Ritonavir on the Pharmacokinetics of the CXCR4 Antagonist AMD070 in Healthy Volunteers. Antimicrob Agents Chemother. 2008 May;52(5):1630-4. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2346642/. Last accessed on January 24, 2017.
  8. National Institute of Allergy and Infectious Diseases (NIAID). Phase IB/IIA Dose-Finding Safety and Activity Study of AMD11070 (An Orally Administered CXCR4 Entry Inhibitor) in HIV-Infected Subjects. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on August 5, 2004. NLM Identifier: NCT00089466. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00089466. Last accessed on January 24, 2017.

Last Reviewed: January 24, 2017