Albuvirtide in Combination With 3BNC117 in Virologically Suppressed Subjects With HIV-1 Infection

NCT04819347 | Unknown Phase 2

• 1 other identifier: ABT-3BNC117_202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI)

  Proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 26.

  Week 26

Secondary Outcomes (7)

• Mean time to virologic rebound (HIV-1 RNA≥200 copies/mL) after ATI

  up to 48 weeks

• Proportion of participants without experiencing virologic rebound (HIV-1 RNA<200 copies/mL) at Week 26 (24 weeks after ATI).

  Week 26

• Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI).

  Week 26

• Mean change in CD4 cell count after ATI

  up to 48 weeks

• Mean change in CD4/CD8 ration after ATI

  up to 48weeks

Study Arms (2)

Early treatment of infection

EXPERIMENTAL

HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA \<50 copies/mL for at least 12 months. Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks.

Drug: Albuvirtide; Drug: 3BNC117

Chronic period of infection treatment

EXPERIMENTAL

Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), and had plasma HIV-1 RNA \<50 copies/mL for at least 12 months. Albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks IV infusion for a total of 14 weeks.

Drug: Albuvirtide; Drug: 3BNC117

Interventions

Albuvirtide DRUG

Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

Also known as: ABT

Chronic period of infection treatment; Early treatment of infection

3BNC117 DRUG

Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.

Chronic period of infection treatment; Early treatment of infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age ≥18 years
• For cohort 1: HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) within 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy within 6 months of PHI.
• For cohort 2: Chronically HIV-1 infected subjects initiated a stable combination antiretroviral therapy (ART) after 6 months of primary HIV infection (PHI), having the document evidence of initial diagnosis of HIV-1 infection and initiation of ART therapy after 6 months of PHI.
• Plasma HIV-1 RNA \<50 copies/mL for at least 12 months prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA \>50 copies/mL) can be considered.
• Plasma HIV-1 RNA \<20 copies/mL at Screening Visit.
• CD4 cell count \>500 cells/µL.
• Laboratory values at Screening of:
• Absolute neutrophil count (ANC) ≥0.75×10∧9/L;
• Hemoglobin (Hb) ≥105 g/L (male) or ≥95 g/L (female);
• Platelets ≥75×10∧9/L;
• Serum alanine transaminase (SGPT/ALT) \< 2 x upper limit of normal (ULN)
• Serum aspartate transaminase (SGOT/AST) \< 2 x ULN
• Bilirubin (total) \<2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
• Creatinine ≤1.5 x ULN
• Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.

You may not qualify if:

• Any active infection or malignancy requiring acute therapy.
• Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg).
• Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening.
• Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
• Unexplained fever or clinically significant illness within 1 week prior to the first study dose
• Any vaccination within 2 weeks prior to the first study dose.
• Subjects BMI\<20 or \>27 kg/m∧2 \[BMI＝weight/height∧2\].
• History of Bleeding Disorder or patients on anti-coagulant therapy
• Participation in an experimental drug trial(s) within 30 days of the Screening Visit
• Any known allergy or antibodies to the study drug or excipients
• Treatment with any of the following:
• Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
• Receipt of any fusion inhibitor and monoclonal antibody therapy of any kind in the past.
• Immunosuppressants within 60 days prior to the Screening Visit
• Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

albuvirtide; 3BNC117 antibody

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng Yao

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Central Study Contacts

Xingxiang Xu

CONTACT

025-69648410; xxxu@frontierbiotech.com

Cheng Yao

CONTACT

yaocheng@frontierbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)