- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369965
Test Albuvirtide in Experienced Patients (TALENT)
Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China
- Beijing Youan Hospital, Capital Medical University
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Beijing, Beijing, China
- Beijing Ditan Hospital, Capital Medical University
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Beijing, Beijing, China
- 302 Hospital People's Liberation Army Of China
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Guangdong
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Guangzhou, Guangdong, China
- Guangzhou Eighth People's Hospital
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Shenzhen, Guangdong, China
- The Third People's Hospital of Shenzhen
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Henan
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Zhengzhou, Henan, China
- Henan Infectious Disease Hospital
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Hunan
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Changsha, Hunan, China
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, China
- The First Hospital of Changsha
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Public Health Clinical Center
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Shanxi
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Xi'an, Shanxi, China
- Tangdu Hospital, Fourth Military Medical University
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Zhejiang
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Hangzhou, Zhejiang, China
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China
- Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 16-60 years old, male or female.
- 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).
- Those who have been undergoing antiretroviral treatment with nucleosides and non-nucleoside reverse transcriptase inhibitors (NRTIs+NNRTIs) for at least 6 months.
- HIV-RNA ≥ 1000 copies/mL.
- 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.).
- 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:
- 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.
- 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.
- Those who have been co-administered antiviral treatment for hepatitis.
- 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.
- Those with allergic constitution or known allergic to ingredients of the investigational drug or ART drugs prescribed in the protocol.
- Currently suffering from serious chronic diseases, metabolic diseases (such as diabetes mellitus), neurological and psychiatric disorders.
- Patients with hemophilia A or B.
- Those with suspected or confirmed history of alcohol or drug abuse.
- Pregnant or lactating women; or women of childbearing age who refuse to take contraceptive measures during the trial.
- 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
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:
lopinavir-ritonavir 400/100mg administered orally twice daily
Other Names:
|
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:
tenofovir 300mg administered orally once daily
Other Names:
lamivudine 300mg administered orally once daily
Other Names:
|
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
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Through Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of viral load
Time Frame: Baseline to Week 48
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Changes of HIV-1 RNA relative to baseline at Week 48
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Baseline to Week 48
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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
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Through Week 48
|
Changes of CD4 cell count
Time Frame: Baseline to Week 48
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Changes of CD4 cell count relative to baseline at Week 48
|
Baseline to Week 48
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dong Xie, Frontier Biotechnologies Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Tenofovir
- Ritonavir
- Lopinavir
- Lamivudine
Other Study ID Numbers
- FB-ABWT-Ⅲ-301
- ChiCTR-TRC-14004276 (Registry Identifier: Chinese Clinical Trial Registry)
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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