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Test Albuvirtide in Experienced Patients (TALENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369965
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Frontier Biotechnologies Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).

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

Detailed Description:

This was a 48-week, multi-center, open-label, randomized and controlled, non-inferiority phase 3 clinical trial to evaluate the safety and efficacy of albuvirtide combined with LPV/r in HIV-1 infected patients who failed their first-line ART and had HIV-1 RNA levels ≥ 1000 copies/mL at screening.

The trial was conducted in 12 sites in China. Subjects meeting inclusion criteria were randomized in a 1:1 ratio to ABT group and NRTI group, in which the ABT group received albuvirtide and LPV/r combination therapy, and NRTI group received the standard 3-drug regimen of LPV/r + Lamivudine (3TC) + Tenofovir (TDF). If TDF was used in the previous regimen or genotypic resistance histories showed primary mutation to TDF, zidovudine (AZT) or abacavir (ABC) would be used. Albuvirtide was given by weekly intravenous infusion and LPV/r was given twice daily orally. A total of 418 subjects were randomized, of whom 401 received at least one treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy
Actual Study Start Date : February 19, 2014
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

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 of virological suppression at Week 48 [ Time Frame: Through Week 48 ]
    Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48


Secondary Outcome Measures :
  1. Changes of viral load [ Time Frame: Baseline to Week 48 ]
    Changes of HIV-1 RNA relative to baseline at Week 48

  2. Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 [ Time Frame: Through Week 48 ]
    Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48

  3. Changes of CD4 cell count [ Time Frame: Baseline to Week 48 ]
    Changes of CD4 cell count relative to baseline at Week 48



Information from the National Library of Medicine

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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. 16-60 years old, male or female.
  2. Those who meet the Diagnostic Criteria of AIDS and HIV Infection, the Health Industry Standard of the People's Republic of China (WS 293-2008).
  3. Those who have been undergoing antiretroviral treatment with nucleosides and non-nucleoside reverse transcriptase inhibitors (NRTIs+NNRTIs) for at least 6 months.
  4. HIV-RNA ≥ 1000 copies/mL.
  5. Those who have no serious hepatic or renal functional impairment and other parameters are generally in the normal ranges according to the comprehensive physical examinations (including general physical examination, routine blood and urine tests, blood chemistry tests, ECG, etc.).
  6. The subjects should have a full understanding of the objective, nature, methods of the trial and the possible reactions. He/She should participate in the trial voluntarily and should sign the informed consent form.

Exclusion Criteria:

  1. Those who are in an acute stage of infection, or have suffered from AIDS-related diseases (e.g. opportunistic infections or malignant tumors, etc.) at enrollment; or have suffered from opportunistic infections within 3 months prior to enrollment and the conditions have not reached a stable state within 2 weeks prior to enrollment.
  2. Those who have used protease inhibitors or HIV fusion inhibitors for antiretroviral treatment, and who have participated in HIV vaccine clinical trials or have participated in other drug trials within recent 3 months.
  3. Those who have been co-administered antiviral treatment for hepatitis.
  4. Those whose screening test results meet one of the following: hemoglobin < 9 g/dL, WBC count <2×109/L, neutrophil count < 1×109/L, PLT count < 75×109/L, transaminase > 3×ULN, total bilirubin > 2×ULN, creatinine > 1×ULN, serum creatine phosphokinase > 2×ULN.
  5. Those with allergic constitution or known allergic to ingredients of the investigational drug or ART drugs prescribed in the protocol.
  6. Currently suffering from serious chronic diseases, metabolic diseases (such as diabetes mellitus), neurological and psychiatric disorders.
  7. Patients with hemophilia A or B.
  8. Those with suspected or confirmed history of alcohol or drug abuse.
  9. Pregnant or lactating women; or women of childbearing age who refuse to take contraceptive measures during the trial.
  10. Those for whom the possibility of being enrolled is low according to the judgment of the investigator (e.g. weak physical condition, poor compliance, etc.).

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


Locations
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China, Beijing
302 Hospital People's Liberation Army Of China
Beijing, Beijing, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing, China
Beijing Youan Hospital, Capital medical university
Beijing, Beijing, China
China, Guangdong
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
The Third People'S Hospital Of Shenzhen
Shenzhen, Guangdong, China
China, Henan
Henan Infectious Disease Hospital
Zhengzhou, Henan, China
China, Hunan
The First Hospital of Changsha
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Shanghai
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shanxi, China
China, Zhejiang
Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Frontier Biotechnologies Inc.
Investigators
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Study Director: Dong Xie Frontier Biotechnologies Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frontier Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT02369965    
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: October 6, 2021
Last Verified: September 2021
Keywords provided by Frontier Biotechnologies Inc.:
HIV-1
AIDS
Albuvirtide
Treatment-experienced
Fusion inhibitor
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Tenofovir
Lamivudine
HIV Protease Inhibitors
Viral 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