AlbuvirtideOther Names: ABT, FB006M Drug Class: Fusion Inhibitor Registry Number: 1417179-66-8 (CAS) Organization: Frontier Biotechnologies Co., Ltd Phase of Development: Albuvirtide is in Phase III development for HIV treatment. Albuvirtide is in Phase III development in China, and an application for marketing approval of the drug was accepted by the China Food and Drug Administration in July 2016.
(Compound details obtained from ChemIDplus Advanced,1 Treatment Action Group 2017 Pipeline Report,2 and Frontier Biotechnologies website.3)
What is an investigational drug?
Anis one that is under study and is not approved by the U.S. (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 What is an Investigational HIV Drug? fact sheet.
What is albuvirtide?
Albuvirtide is an investigational drug that is being studied for the treatment of HIV.2
Albuvirtide belongs to a class (group) of HIV drugs calledinhibitors. Fusion inhibitors block HIV from getting into and infecting certain cells of the . This prevents HIV from multiplying and can reduce the amount of HIV in the body.
Albuvirtide works by attaching to aon the outer surface of HIV. This protein is called the protein. By attaching to the gp41 envelope protein, albuvirtide blocks HIV from getting into and infecting the immune cells.4
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 IIIto 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 albuvirtide?
Albuvirtide is in Phase III development for HIV treatment.2
What are some studies on albuvirtide?
Study Name: ChiCTR-TRC-13003140
Sponsor: Frontier Biotechnologies Co., Ltd
Status: This study has been completed.
- Participants were adults with HIV who had never taken HIV medicines before entering the study.
- Participants had levels (the amount of HIV in a blood sample) between 5,000 and 1,000,000 copies/mL. They also had CD4 counts greater than 350 cells/mm3. (A is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)
Study Names: TALENT; NCT02369965
Sponsor: Frontier Biotechnologies Co., Ltd
Status: The status of this study is unknown.
- Participants are children and adults (ages 16 to 60 years) with HIV who have previously received (ART) with inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) for more than 6 months. (ART is the recommended treatment for HIV infection and involves using a combination of different [ARV] drugs to prevent HIV from multiplying.)
- Participants have had while on their first standard ART regimen. (Treatment failure is when an ART regimen is unable to control HIV infection.)
- Participants have viral load levels of at least 1,000 copies/mL.
Purpose: The purpose of this study is to determine the safety and effectiveness of albuvirtide plus lopinavir/ritonavir.7,8
For more details on the studies listed above, see the Health Professional version of this information.
What side effects might albuvirtide cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following is information on side effects observed in the studies of albuvirtide listed above.
In this Phase II study, none of the participants had serious side effects. They did have some mild side effects related to albuvirtide, including nausea, diarrhea, rash, and increased triglyceride levels.6
In this Phase III study, 6 participants receiving albuvirtide had a serious side effect, but none of them were related to albuvirtide. Overall, the most commonly reported side effects associated with albuvirtide treatment were mild to moderate diarrhea, headache, and dizziness. Among participants receiving albuvirtide, the most common abnormal blood test results were high and increased triglyceride levels.7
Because albuvirtide is still being studied, information on possible side effects of the drug is not complete. As testing of albuvirtide continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying albuvirtide?
More information about albuvirtide-related research studies is available from the AIDSinfo database of 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.
- United States National Library of Medicine. ChemIDplus Advanced. Available at: https://chem.nlm.nih.gov/chemidplus/rn/1417179-66-8. Last accessed on October 19, 2017.
- Frick M, Gaudino A, Harrington M, et al. Treatment Action Group. 2017 pipeline report. July 2017. Available at: http://www.pipelinereport.org/sites/default/files/2017%20Pipeline%20Report%20Final.pdf. Last accessed on October 19, 2017.
- Frontier Biotechnologies website. Product: long-acting peptide drug discovery and development platform. Available at: http://www.frontierbiotech.com/en/products/2.html. Last accessed on October 19, 2017.
- Chong H, Yao X, Zhang C, et al. Biophysical property and broad anti-HIV activity of albuvirtide, a 3-maleimimidopropionic acid-modified peptide fusion inhibitor. PLoS One. 2012;7(3):e32599. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293837/. Last accessed on October 19, 2017.
- National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on October 19, 2017.
- Zhang H, Jin R, Yao C, et al. Combination of long-acting HIV fusion inhibitor albuvirtide and LPV/r showed potent efficacy in HIV-1 patients. AIDS Res Ther. 2016 Feb 10;13:8. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4748529/. Last accessed on October 19, 2017.
- Xie D. Efficacy and safety of long acting HIV fusion inhibitor albuvirtide in antiretroviral-experienced adults with HIV-1: interim 48 week results from the randomized, controlled, phase 3, non-inferiority TALENT study. Webcast presented at: International Congress of Drug Therapy in HIV Infection (HIV Glasgow); October 23-26, 2016; Glasgow, United Kingdom. Available at: https://vimeo.com/189136480. Last accessed on October 19, 2017.
- Frontier Biotechnologies Co., Ltd. Efficacy and safety of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults failed standard first-line ART regimen. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 24, 2015. NLM Identifier: NCT02369965. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02369965. Last accessed on October 19, 2017.
Last Reviewed: October 19, 2017