Test Albuvirtide in Experienced Patients

HIV Infections Clinical Trial

— TALENT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369965
• Other study ID #: FB-ABWT-?-301
• Secondary ID: ChiCTR-TRC-14004
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2014
• Est. completion date: April 2, 2018

Study information

• Verified date: September 2021
• Source: Frontier Biotechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.).

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• albuvirtide
albuvirtide 320mg administered intravenously once a week
• lopinavir-ritonavir
lopinavir-ritonavir 400/100mg administered orally twice daily
• tenofovir
tenofovir 300mg administered orally once daily
• lamivudine
lamivudine 300mg administered orally once daily

Locations

Country	Name	City	State
China	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	The First Hospital of Changsha	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital Zhejiang University School Of Medicine	Hangzhou	Zhejiang
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The Third People'S Hospital Of Shenzhen	Shenzhen	Guangdong
China	Tangdu Hospital, Fourth Military Medical University	Xi'an	Shanxi
China	Henan Infectious Disease Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Biotechnologies Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of viral load	Changes of HIV-1 RNA relative to baseline at Week 48	Baseline to Week 48
Secondary	Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48	Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48	Through Week 48
Secondary	Changes of CD4 cell count	Changes of CD4 cell count relative to baseline at Week 48	Baseline to Week 48