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Trial record 92 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

Test Albuvirtide in Experienced Patients (TALENT)

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ClinicalTrials.gov Identifier: NCT02369965
Recruitment Status : Unknown
Verified February 2015 by Frontier Biotechnologies Inc..
Recruitment status was:  Recruiting
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Frontier Biotechnologies Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections AIDS Drug: albuvirtide Drug: lopinavir-ritonavir Drug: tenofovir Drug: lamivudine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
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
Study Start Date : January 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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 Names:
  • 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 Names:
  • 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




Primary Outcome Measures :
  1. Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: week 48 ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369965


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

Locations
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China, Beijing
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         
China, Guangdong
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         
China, Henan
Henan Infectious Disease Hospital Recruiting
Zhengzhou, Henan, China
Contact: Qingxia Zhao         
Principal Investigator: Qingxia Zhao         
China, Hunan
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         
China, Liaoning
Dalian Sixth People's Hospital Not yet recruiting
Dalian, Liaoning, China
Contact: Zhenxing Cui         
Principal Investigator: Zhenxing Cui         
China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China
Contact: Hongzhou Lu         
Principal Investigator: Hongzhou Lu         
China, Shanxi
Tangdu Hospital of the Forth Military Medical University Recruiting
Xi'an, Shanxi, China
Contact: Yongtao Sun         
Principal Investigator: Yongtao Sun         
China, Zhejiang
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
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Study Director: Dong Xie Frontier Biotechnologies Inc.

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Responsible Party: Frontier Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT02369965     History of Changes
Other Study ID Numbers: FB-ABWT-Ⅲ-301
ChiCTR-TRC-14004276 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Frontier Biotechnologies Inc.:
HIV-1
AIDS
Albuvirtide
Treatment-experienced
Fusion inhibitor
Additional relevant MeSH terms:
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RNA Virus Infections
Virus Diseases
Lopinavir
HIV Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Tenofovir
Lamivudine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors