Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06032546
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-09-05
Brief Title:
A Study to Assess Change in Disease Activity Adverse Events and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus HIV Receiving Intravenous IV Infusion or Subcutaneous SC Injection of Budigalimab andor ABBV-382
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-controlled Study to Evaluate Efficacy Safety Tolerability and Pharmacokinetics of Budigalimab andor ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Human immuno-deficiency virus HIV is the virus that causes Acquired Immuno-Deficiency Syndrome AIDS HIV disease is considered to be a chronic disease requiring lifelong therapy The purpose of this study is to assess change in disease activity adverse events tolerability and how the drug moves through the body
Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease In Part 1 participants are placed in 1 of 5 groups called treatment arms Each group receives a different treatment There is a 1 in 7 chance that participants will be assigned to placebo A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness In Part 2 eligible participants will be placed in an open-label arm to receive Budigalimab Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy ART willing to undergo Analytical Treatment Interruption ATI will be enrolled at approximately 90 sites worldwide
In Part 1 participants will receive 4 doses of intravenous IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period In Part 2 participants will receive 4 doses of open-label subcutaneous SC Budigalimab for a 6 week dosing period Participants need to be stable on antiretroviral therapy to participate in the study If participant qualifies to the study on the day they receive the first injection participants will be asked to stop antiretroviral medications also referred to as analytical treatment interruption or ATI for 112 weeks or until meeting specific criteria to restart antiretroviral medications Participants will undergo a closely monitored ART interruption Protocol-defined ART restart criteria includes participants request Participants will be followed for up to approximately 112 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic There will be an option for virtual or home health visits for some of the follow-up visits The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease In Part 1 participants are placed in 1 of 5 groups called treatment arms Each group receives a different treatment There is a 1 in 7 chance that participants will be assigned to placebo A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness In Part 2 eligible participants will be placed in an open-label arm to receive Budigalimab Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy ART willing to undergo Analytical Treatment Interruption ATI will be enrolled at approximately 90 sites worldwide
In Part 1 participants will receive 4 doses of intravenous IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period In Part 2 participants will receive 4 doses of open-label subcutaneous SC Budigalimab for a 6 week dosing period Participants need to be stable on antiretroviral therapy to participate in the study If participant qualifies to the study on the day they receive the first injection participants will be asked to stop antiretroviral medications also referred to as analytical treatment interruption or ATI for 112 weeks or until meeting specific criteria to restart antiretroviral medications Participants will undergo a closely monitored ART interruption Protocol-defined ART restart criteria includes participants request Participants will be followed for up to approximately 112 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic There will be an option for virtual or home health visits for some of the follow-up visits The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505900-53-00 | OTHER | EU CT | None |