Test Albuvirtide in Experienced Patients

NCT ID: NCT02369965

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-19
• Study Completion Date: 2018-04-02

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).

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.

Conditions

HIV Infections; AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

albuvirtide, lopinavir-ritonavir

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

Group Type: EXPERIMENTAL

albuvirtide

Intervention Type: DRUG

albuvirtide 320mg administered intravenously once a week

lopinavir-ritonavir

Intervention Type: DRUG

lopinavir-ritonavir 400/100mg administered orally twice daily

lopinavir-ritonavir,tenofovir,lamivudine

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

Group Type: ACTIVE_COMPARATOR

lopinavir-ritonavir

Intervention Type: DRUG

lopinavir-ritonavir 400/100mg administered orally twice daily

tenofovir

Intervention Type: DRUG

tenofovir 300mg administered orally once daily

lamivudine

Intervention Type: DRUG

lamivudine 300mg administered orally once daily

Interventions

albuvirtide

albuvirtide 320mg administered intravenously once a week

Intervention Type: DRUG

lopinavir-ritonavir

lopinavir-ritonavir 400/100mg administered orally twice daily

Intervention Type: DRUG

tenofovir

tenofovir 300mg administered orally once daily

Intervention Type: DRUG

lamivudine

lamivudine 300mg administered orally once daily

Intervention Type: DRUG

Other Intervention Names

ABT; Kaletra; LPV/r; TDF; 3TC

Eligibility 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.).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frontier Biotechnologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong Xie

Role: STUDY_DIRECTOR

Frontier Biotechnologies Inc.

Locations

302 Hospital People's Liberation Army Of China

Beijing, Beijing Municipality, China

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Youan Hospital, Capital medical university

Beijing, Beijing Municipality, China

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

The Third People'S Hospital Of Shenzhen

Shenzhen, Guangdong, China

Henan Infectious Disease Hospital

Zhengzhou, Henan, China

The First Hospital of Changsha

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Tangdu Hospital, Fourth Military Medical University

Xi’an, Shanxi, 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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33252379 (View on PubMed)

Other Identifiers

ChiCTR-TRC-14004276

Identifier Type: REGISTRY

Identifier Source: secondary_id

FB-ABWT-Ⅲ-301

Identifier Type: -

Identifier Source: org_study_id