HIV: Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

8 Apr 2024 → 22 Sep 2025

Decision date (initial)

2024-03-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-505900-53-00

ClinicalTrials.gov

NCT06032546

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

To evaluate efficacy, safety, tolerability, and PK of budigalimab and/or ABBV-382 versus placebo in PLWH on stable ART undergoing ATI.

Conditions and MedDRA coding

HIV infection

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. PLWH between 18-70 years old, in general good health and on ART for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.
2. Participants must have negative HIV-2 Ab at screening; plasma HIV-1 RNA below LLOQ at screening and for at least 12 months prior to screening; and CD4+ T cell count ≥ 500 cells/μL at screening and no known evidence of CD4+ T cell count < 500 cells/μL in the last 12 months prior to screening.

Exclusion criteria 3

1. Participants that have had prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug.
2. Participants have known history of CD4+ T cell nadir of ≤ 200 cells/μL during chronic HIV infection.
3. Participants with clinically significant medical disorders per investigator's assessment that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Viral control (viral load < 1000 copies/mL) at Week 24 without ART restart.

Secondary endpoints 2

1. Peak viral load (at rebound) prior to re-starting ART.
2. Time to first rebound to ≥ 1000 copies/mL during ART interruption.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 7

Locations

7 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 59 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications