Test Albuvirtide in Experienced Patients (TALENT)

September 28, 2021 updated by: Frontier Biotechnologies Inc.

Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Beijing Ditan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • 302 Hospital People's Liberation Army Of China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangzhou Eighth People's Hospital
      • Shenzhen, Guangdong, China
        • The Third People's Hospital of Shenzhen
    • Henan
      • Zhengzhou, Henan, China
        • Henan Infectious Disease Hospital
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • The First Hospital of Changsha
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Public Health Clinical Center
    • Shanxi
      • Xi'an, Shanxi, China
        • Tangdu Hospital, Fourth Military Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: albuvirtide, lopinavir-ritonavir
albuvirtide once a week and lopinavir-ritonavir twice daily for 48 weeks
albuvirtide 320mg administered intravenously once a week
Other Names:
  • ABT
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
lopinavir-ritonavir 400/100mg administered orally twice daily
Other Names:
  • Kaletra
  • LPV/r
tenofovir 300mg administered orally once daily
Other Names:
  • TDF
lamivudine 300mg administered orally once daily
Other Names:
  • 3TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of viral load
Time Frame: Baseline to Week 48
Changes of HIV-1 RNA relative to baseline at Week 48
Baseline to Week 48
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
Through Week 48
Changes of CD4 cell count
Time Frame: Baseline to Week 48
Changes of CD4 cell count relative to baseline at Week 48
Baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Dong Xie, Frontier Biotechnologies Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2014

Primary Completion (Actual)

April 2, 2018

Study Completion (Actual)

April 2, 2018

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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