NCT03719664|UnknownPhase 2DMCFDA Drug

Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects

ABL

A Phase 2, Multicenter, Three-part Study to Establish the Dosage, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects With HIV-1 Infection

Frontier Biotechnologies Inc.ClinicalTrials.gov

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1 other identifier

ABT-3BNC117_201

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2018

StartedDec 2018

CompletionDec 2022

Brief Summary

The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Dec 2018

Typical duration for phase_2

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

October 22, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed

Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

October 22, 2018

Last Update Submit

September 28, 2021

Conditions

HIV-1-infection

Keywords

HIV-13BNC117AlbuvirtideBroadly neutralizing antibodyLong-Acting HIV-1 Fusion Inhibitor

Outcome Measures

Primary Outcomes (1)

Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study.
28 weeks in Part 3

Secondary Outcomes (10)

Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 1 of the study
16 weeks in Part 1
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 2 of the study
16 weeks in Part 2
Time to virologic rebound after discontinuation of baseline ART regimen
16 weeks in Part 1 and part 2, 28 weeks in part 3
Proportion of participants achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
16 weeks in Part 1 and part 2, 28 weeks in part 3
Time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
16 weeks in Part 1 and part 2, 28 weeks in part 3
+5 more secondary outcomes

Study Arms (7)

Cohort 1: albuvirtide & 3BNC117

EXPERIMENTAL

albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks

Drug: AlbuvirtideDrug: 3BNC117

Cohort 2: albuvirtide & 3BNC117

EXPERIMENTAL

albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks

Drug: AlbuvirtideDrug: 3BNC117

Control Arm 1: Baseline ART

ACTIVE COMPARATOR

Subjects continuing on baseline ART

Drug: Baseline ART

Cohort 3: albuvirtide & 3BNC117

EXPERIMENTAL

albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks

Drug: AlbuvirtideDrug: 3BNC117

Cohort 4: albuvirtide & 3BNC117

EXPERIMENTAL

albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks

Drug: AlbuvirtideDrug: 3BNC117

Optimal Dose: albuvirtide & 3BNC117

EXPERIMENTAL

albuvirtide and 3BNC117 every 2 or 4 weeks

Drug: AlbuvirtideDrug: 3BNC117

Control Arm 2: Baseline ART

ACTIVE COMPARATOR

Subjects continuing on baseline ART

Drug: Baseline ART

Interventions

AlbuvirtideDRUG

Intravenous infusion of Albuvirtide

Also known as: Fusion inhibitor

Cohort 1: albuvirtide & 3BNC117Cohort 2: albuvirtide & 3BNC117Cohort 3: albuvirtide & 3BNC117Cohort 4: albuvirtide & 3BNC117Optimal Dose: albuvirtide & 3BNC117

3BNC117DRUG

Intravenous infusion of 3BNC117

Also known as: Monoclonal antibody

Cohort 1: albuvirtide & 3BNC117Cohort 2: albuvirtide & 3BNC117Cohort 3: albuvirtide & 3BNC117Cohort 4: albuvirtide & 3BNC117Optimal Dose: albuvirtide & 3BNC117

Baseline ARTDRUG

Subjects continuing on baseline ART

Also known as: ART

Control Arm 1: Baseline ARTControl Arm 2: Baseline ART

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Potential subjects are required to meet all of the following criteria for enrollment into the study.
HIV-1 seropositive;
Males and females, age ≥18 years;
Receiving oral combination antiretroviral therapy for last 24 weeks;
No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit with an exception that subjects on NNRTI-containing regimens will be allowed to switch to protease inhibitor- or integrase strand transferase inhibitor-based regimens and such change, if needed, should occur at least 4 weeks prior to cessation of oral antiretroviral therapy;
Subject has two or more potential alternative antiretroviral drug options available;
Plasma HIV-1 RNA \<50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR);
No documented detectable viral loads (HIV-1 RNA \> 50 copies/mL) within the last 24 weeks prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA \<400 copies/mL) can be considered, although the preceding and following HIV-1 RNA measurements should be \<50 copies/mL;
CD4 cell count of \>300 cells/mm3 at Screening Visit;
Laboratory values at Screening:
Absolute neutrophil count (ANC) ≥750/ mm3;
Hemoglobin (Hb) ≥10.5 gm/dL (male) or ≥9.5 gm/dL (female);
Platelets ≥75,000 /mm3;
Serum alanine transaminase (SGPT/ALT) \<1.25 x upper limit of normal (ULN);
Serum aspartate transaminase (SGOT/AST) \<1.25 x ULN;
+6 more criteria

You may not qualify if:

Potential subjects meeting any of the following criteria will be excluded from enrollment.
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;
Grade 4 DAIDS laboratory abnormality;
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 weighing \<35kg;
History of anaphylaxis to any oral or parenteral drugs;
Use of any fusion inhibitors and broadly neutralizing monoclonal antibody prior to the Screening Visit;
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;
+4 more criteria

Contact the study team to confirm eligibility.