Clinical Trials

MainTitle

Test Albuvirtide in Experienced Patients (TALENT)

The recruitment status of this study is unknown.

Verified February 2015 by Frontier Biotechnologies Inc.

Sponsor
Frontier Biotechnologies Inc.


Information provided by (Responsible Party)
Frontier Biotechnologies Inc.
ClinicalTrials.gov Identifier
NCT02369965

First received: February 18, 2015
Last updated: February 18, 2015
Last Verified: February 2015
History of Changes
Purpose

Purpose

The purpose of this study is to determine the efficacy and safety of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.

Condition Intervention Phase
HIV Infections
AIDS

Drug : albuvirtide
Drug : lopinavir-ritonavir
Drug : tenofovir
Drug : lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Albuvirtide Plus Lopinavir-ritonavir in HIV-1-infected Adults Failed Standard First-line ART Regimen

Further study details as provided by Frontier Biotechnologies Inc.:

Primary Outcome Measures

  • Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: week 48 ]
Secondary Outcome Measures:
  • Change from baseline through Week 48 in HIV-1 RNA [ Time Frame: from baseline to 48 weeks ]
  • Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 [ Time Frame: week 48 ]
  • Change from baseline through Week 48 in CD4 count [ Time Frame: from baseline to 48 weeks ]

Estimated Enrollment: 420
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: albuvirtide, lopinavir-ritonavir
albuvirtide once a week and lopinavir-ritonavir twice daily for 48 weeks
Drug: albuvirtide

albuvirtide 320mg administered intravenously once a week

Other Name: ABT
Drug: lopinavir-ritonavir

lopinavir-ritonavir 400/100mg administered orally twice daily

Other Name:
  • Kaletra
  • LPV/r

Active Comparator: lopinavir-ritonavir,tenofovir,lamivudine
lopinavir-ritonavir twice daily, tenofovir once daily and lamivudine once daily for 48 weeks
Drug: lopinavir-ritonavir

lopinavir-ritonavir 400/100mg administered orally twice daily

Other Name:
  • Kaletra
  • LPV/r

Drug: tenofovir

tenofovir 300mg administered orally once daily

Other Name: TDF
Drug: lamivudine

lamivudine 300mg administered orally once daily

Other Name: 3TC

Detailed Description:

This is a 48-week, randomized, controlled, open-label, multicenter study of the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1 infected adults who are failing their first antiretroviral regimen and have HIV-1 RNA levels >= 1000 copies/mL at screening.
Subjects meeting inclusion criteria are randomized in a 1:1 ratio to receive either albuvirtide + lopinavir-ritonavir or lopinavir-ritonavir + TDF + 3TC. If TDF is used in the current regimen or genotypic resistance test shows primary mutation to TDF, zidovudine (AZT) or abacavir will be used. Albuvirtide will be given by weekly intravenous infusion and LPV/r will be given twice daily. The primary end point is the percentage of participants with HIV-1 RNA<50 copies/mL at Week 48, the secondary end points include the change of HIV-1 RNA from baseline through Week 48, the percentage of participants with HIV-1 RNA<400 copies/mL at Week 48, and the change of CD4 count from baseline through Week 48.

Eligibility

Eligibility

Ages Eligible for Study: 16 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Male or female patients aged 16 to 60 years old;
    2. Previously documented HIV infection on standard antibody-based test;
    3. Previous antiretroviral therapy (ART) with NRTIs/NNRTIs for more than 6 months;
    4. HIV RNA≥1000 copies/ml;
    5. In healthy condition by physical examination, biochemistry, hematology and urinalysis test,and electrocardiogram etc., without serious liver and renal damages;
    6. Fully understand the purpose, characteristics, procedures of the trial, and the potentially adverse events which might occur during study; willing and able to sign informed consent.


Exclusion Criteria:
    1. Patients with acute HIV infection,or with AIDS-related disease, such as severe opportunistic infection or tumors;
    2. Previously received any protease inhibitors, HIV fusion inhibitors, HIV vaccines, or received other investigational drugs within 3 months;
    3. Co-treatment against hepatitis virus;
    4. Having abnormal values at screening as follows: Hemoglobin<9g/dL, White blood count <2×10^9/L, Neutrophil <1×10^9/L, Platelet count <75×10^9/L, Aminopherase >3-fold upper limit of normal value, Total bilirubin >2-fold upper limit of normal value, Creatinine >upper limit of normal value, Creatine phosphokinase >2-fold upper limit of normal value;
    5. With allergic constitution, or allergic history of the investigational drug and ART drugs;
    6. With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease;
    7. Had a history of hemophilia A or B;
    8. Alcohol abuse or drug abuse;
    9. Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control;
    10. Unsuitable to participate in this study in the opinion of the site investigator.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02369965

Contacts

Contact:   Cheng Yao +86 025 87158168 yaocheng@frontierbiotech.com

Locations

China
302 Military Hospital of China Recruiting
Beijing, Beijing, China
Contact: Min Zhao
Principal Investigator: Min Zhao
Beijing Ditan Hospital, Capital medical university Recruiting
Beijing, Beijing, China
Contact: Hongxing Zhao
Principal Investigator: Hongxing Zhao
Beijing YouAn Hospital, Capital medical university Recruiting
Beijing, Beijing, China
Contact: Hao Wu
Principal Investigator: Hao Wu
Guangzhou Eighth People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Weiping Cai
Principal Investigator: Weiping Cai
Shenzhen Third People's Hospital Not yet recruiting
Shenzhen, Guangdong, China
Contact: Hui Wang
Principal Investigator: Hui Wang
Henan Infectious Disease Hospital Recruiting
Zhengzhou, Henan, China
Contact: Qingxia Zhao
Principal Investigator: Qingxia Zhao
The First Hospital of Changsha Recruiting
Changsha, Hunan, China
Contact: Min Wang
Principal Investigator: Min Wang
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Yuhuang Zheng
Principal Investigator: Yuhuang Zheng
Dalian Sixth People's Hospital Not yet recruiting
Dalian, Liaoning, China
Contact: Zhenxing Cui
Principal Investigator: Zhenxing Cui
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China
Contact: Hongzhou Lu
Principal Investigator: Hongzhou Lu
Tangdu Hospital of the Forth Military Medical University Recruiting
Xi'an, Shanxi, China
Contact: Yongtao Sun
Principal Investigator: Yongtao Sun
The First Affiliated Hospital of College of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Jifang Sheng
Principal Investigator: Jifang Sheng

Sponsors and Collaborators

Frontier Biotechnologies Inc.

Investigators

Study Director: Dong Xie Frontier Biotechnologies Inc.
More Information

More Information


Responsible Party: Frontier Biotechnologies Inc.  
ClinicalTrials.gov Identifier: NCT02369965   History of Changes  
Other Study ID Numbers: FB-ABWT-Ⅲ-301  
  ChiCTR-TRC-14004276  
Study First Received: February 18, 2015  
Last Updated: February 18, 2015  

Keywords provided by Frontier Biotechnologies Inc.:

HIV-1
AIDS
Albuvirtide
Treatment-experienced
Fusion inhibitor

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Tenofovir
Lamivudine

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.