Test Albuvirtide in Experienced Patients

NCT02369965 | Completed Phase 3 DMC

• 2 other identifiers: FB-ABWT-Ⅲ-301ChiCTR-TRC-14004276
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 12

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).

Conditions

HIV Infections; AIDS

Keywords

HIV-1; AIDS; Albuvirtide; Treatment-experienced; Fusion inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of participants of virological suppression at Week 48

  Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48

  Through Week 48

Secondary Outcomes (3)

• Changes of viral load

  Baseline to Week 48

• Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48

  Through Week 48

• Changes of CD4 cell count

  Baseline to Week 48

Study Arms (2)

albuvirtide, lopinavir-ritonavir

EXPERIMENTAL

albuvirtide once a week and lopinavir-ritonavir twice daily for 48 weeks

Drug: albuvirtide; Drug: lopinavir-ritonavir

lopinavir-ritonavir,tenofovir,lamivudine

ACTIVE COMPARATOR

lopinavir-ritonavir twice daily, tenofovir once daily and lamivudine once daily for 48 weeks

Drug: lopinavir-ritonavir; Drug: tenofovir; Drug: lamivudine

Interventions

albuvirtide DRUG

albuvirtide 320mg administered intravenously once a week

Also known as: ABT

albuvirtide, lopinavir-ritonavir

lopinavir-ritonavir DRUG

lopinavir-ritonavir 400/100mg administered orally twice daily

Also known as: Kaletra, LPV/r

albuvirtide, lopinavir-ritonavir; lopinavir-ritonavir,tenofovir,lamivudine

tenofovir DRUG

tenofovir 300mg administered orally once daily

Also known as: TDF

lopinavir-ritonavir,tenofovir,lamivudine

lamivudine DRUG

lamivudine 300mg administered orally once daily

Also known as: 3TC

lopinavir-ritonavir,tenofovir,lamivudine

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (12)

302 Hospital People's Liberation Army Of China

Beijing, Beijing Municipality, China

Location

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Youan Hospital, Capital medical university

Beijing, Beijing Municipality, China

Location

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Location

The Third People'S Hospital Of Shenzhen

Shenzhen, Guangdong, China

Location

Henan Infectious Disease Hospital

Zhengzhou, Henan, China

Location

The First Hospital of Changsha

Changsha, Hunan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Tangdu Hospital, Fourth Military Medical University

Xi’an, Shanxi, China

Location

Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Su B, Yao C, Zhao QX, Cai WP, Wang M, Lu HZ, Chen YY, Liu L, Wang H, He Y, Zheng YH, Li LH, Chen JF, Yu JH, Zhu B, Zhao M, Sun YT, Lun WH, Xia W, Sun LJ, Dai LL, Jiang TY, Wang MX, Zheng QS, Peng HY, Wang Y, Lu RJ, Hu JH, Xing H, Shao YM, Xie D, Zhang T, Zhang FJ, Wu H; TALENT Study Team. Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study. Chin Med J (Engl). 2020 Nov 25;133(24):2919-2927. doi: 10.1097/CM9.0000000000001273.

  PMID: 33252379 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

albuvirtide; Lopinavir; lopinavir-ritonavir drug combination; Tenofovir; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Dong Xie

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 24, 2015
• Study Start: February 19, 2014
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

CN (12)