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Monoclonal Antibodies

ABBV-382 for HIV/AIDS

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 57 to day 225

Awards & highlights

Study Summary

This trial will evaluate the safety and tolerability of ABBV-382 in adult participants with HIV-1 infection.

Eligible Conditions

HIV/AIDS

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 57 to day 225

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 57 to day 225

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 to day 225 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)

Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A)

Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A)

+7 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Subcutaneous Cohort: ABBV-382Experimental Treatment1 Intervention

Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.

Group II: Part B: Intravenous Cohort: ABBV-382 Dose BExperimental Treatment1 Intervention

Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.

Group III: Part B: Intravenous Cohort: ABBV-382 Dose AExperimental Treatment1 Intervention

Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.

Group IV: Part A: ABBV-382 Dose BExperimental Treatment1 Intervention

Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.

Group V: Part A: ABBV-382 Dose AExperimental Treatment1 Intervention

Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.

Group VI: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose APlacebo Group1 Intervention

Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.

Group VII: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose BPlacebo Group1 Intervention

Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-382

2021

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,051 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,885 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this medical trial impose an age limit of 80 or below?

"This clinical trial is recruiting adults aged 18-65 years old."

Answered by AI

Does ABBV-382 pose any potential risks for individuals taking it?

"ABBV-382's safety rating is 1, as the current clinical trial phase only provides minimal data on its efficacy and security."

Answered by AI

Are there any open enrollment opportunities for this clinical research?

"Clinicaltrials.gov affirms that the recruiting phase for this medical experiment is open, with its inception occurring on April 16th 2021 and latest amendment being made September 28th 2022."

Answered by AI

May I be considered for participation in this clinical study?

"To qualify for this trial, applicants must have antibody deficiency syndrome and be between 18-65 years of age. Approximately 52 participants are sought after."

Answered by AI

How many facilities are being utilized for the management of this clinical trial?

"At the moment, 18 different medical centres are recruiting participants for this trial. Locations range from Decatur to Manhasset and Fort Pierce with other sites scattered across the country. To reduce transit time it is wise to pick a clinic near you if possible."

Answered by AI

How many individuals have been recruited for this research study?

"This trial requires 52 volunteers, who satisfy the predetermined criteria, to participate. They can join from iResearch Atlanta (ID# 225526) in Decatur or North Shore University Hospital Manhasset (ID# 223343)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)

2021. "Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04554966.