Albuvirtide is in Phase 3 development for HIV treatment. In June 2018, albuvirtide received marketing approval in China for the treatment of HIV.
(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 and Treatment Action Group Pipeline Report 20193)
What is albuvirtide?
Albuvirtide is anthat is being studied to treat HIV .3
Albuvirtide belongs to a group of HIV drugs calledinhibitors. Albuvirtide works by attaching to a on 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 certain cells of the .4
Which clinical trials are studying albuvirtide?
Study Name: ChiCTR-TRC-13003140
Status: This study has been completed.
Purpose: The purpose of this study was to evaluate 1) the between albuvirtide and the -approved, drug lopinavir/ritonavir (brand name: Kaletra) and 2) the short-term safety and effectiveness of albuvirtide plus lopinavir/ritonavir.5
Study Names: TALENT; NCT02369965
Status: The recruitment status of this study is unknown.
Purpose: The purpose of this study is to compare the safety and effectiveness of albuvirtide plus lopinavir/ritonavir to the safety and effectiveness of lopinavir/ritonavir plus two inhibitors (NRTIs).6
Study Name: NCT03719664
Status: This study is currently recruiting participants.
Location: United States
Purpose: The purpose of this study is to establish the optimal doses for a regimen that includes albuvirtide and another investigational drug, 3BNC117. The study will also evaluate the safety and effectiveness of this regimen.7
For more details on the studies listed above, see the Health Professional version of this drug summary.
What side effects might albuvirtide cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of albuvirtide listed above.ChiCTR-TRC-13003140:
In this Phase 2 study, none of the participants had serious side effects. Some participants did have some mild side effects that were associated with the use of albuvirtide, including nausea, diarrhea, rash, and increased triglyceride levels.5TALENT (NCT02369965):
In this Phase 3 study, six participants who received albuvirtide had a serious side effect, but none of the side effects were related to the use of albuvirtide. Overall, the most commonly reported side effects that were associated with albuvirtide were mild to moderate diarrhea, headache, and dizziness. Among the participants who received albuvirtide, the most common abnormal blood test results were highand increased triglyceride levels, with the majority of these cases being mild to moderate in intensity. High cholesterol occurred more frequently in participants taking albuvirtide than in those taking NRTIs.8
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-relatedresearch studies is available from ClinicalTrials.gov.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For more information, visit
- United States National Library of Medicine. ChemIDplus Advanced: albuvirtide. https://chem.nlm.nih.gov/chemidplus/rn/1417179-66-8. Accessed August 1, 2019
- National Institute of Allergy and Infectious Diseases (NIAID). NIAID ChemDB, HIV Drugs in Development. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Accessed August 1, 2019
- Jefferys R. Antiretroviral Therapy Pipeline 2019. Treatment Action Group Pipeline Report 2019. http://www.treatmentactiongroup.org/sites/default/files/pipeline_arv_therapy_2019.pdf. Accessed August 1, 2019
- 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). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293837/. Accessed August 1, 2019
- 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;13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4748529/. Accessed August 1, 2019
- Frontier Biotechnologies Inc. 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 18, 2015. NLM Identifier: NCT02369965. https://clinicaltrials.gov/ct2/show/NCT02369965. Accessed August 1, 2019
- Frontier Biotechnologies Inc. A Phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 22, 2018. NLM Identifier: NCT03719664. https://clinicaltrials.gov/ct2/show/NCT03719664. Accessed August 1, 2019
- 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. https://vimeo.com/189136480. Accessed August 1, 2019
Last Reviewed: August 1, 2019