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NCT04554966 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Human Immunodeficiency Virus (HIV), sponsored by AbbVie.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
20
Study locations

NCT04554966 is a Phase 1 study of Human Immunodeficiency Virus (HIV) that has completed, run by AbbVie. The registered enrollment target is 54 participants, below the 506-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04554966, a Phase 1 study of Human Immunodeficiency Virus (HIV), has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
20
Study locations

Study Summary

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in adult participants with HIV-1 infection. ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection. This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC) groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded which means neither the study doctors nor the participants will know who will be given study drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at approximately 21 sites across the United States, including Puerto Rico. Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1. Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and 57. There may be a 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. The effect of the treatment will be checked by medical assessments, blood tests, and presence of side effects.

Conditions Studied

Human Immunodeficiency Virus (HIV)

Interventions

  • DRUG ABBV-382
  • DRUG Placebo for ABBV-382

Study Locations (20)

Florida

  • Midway Immunology and Research Center /ID# 223500 - Ft. Pierce
  • Orlando Immunology Center /ID# 223498 - Orlando
  • St. Joseph Comprehensive Research Institute /ID# 246232 - Tampa
  • Triple O Research Institute /ID# 223460 - West Palm Beach

Texas

  • Central Texas Clinical Research /ID# 223378 - Austin
  • Prism Health North Texas - Oak Cliff Health Center /ID# 223237 - Dallas
  • North Texas Infectious Diseases Consultants, P.A /ID# 223236 - Dallas
  • The Crofoot Research Center, Inc /ID# 223383 - Houston

California

  • Franco Felizarta, Md /Id# 223815 - Bakersfield
  • Ruane Clinical Research Group /ID# 224125 - Los Angeles
  • Quest Clinical Research /ID# 223347 - San Francisco

Georgia

  • CenExcel iResearch LLC /ID# 225526 - Decatur
  • Infinite Clinical Trials - Morrow /ID# 225455 - Morrow

District of Columbia

  • George Washington University Medical Faculty Associates /ID# 223493 - Washington D.C.

Iowa

  • University of Iowa Hospitals and Clinics /ID# 224267 - Iowa City

Michigan

  • Be Well Medical Center /ID# 223381 - Berkley

New York

  • North Shore University Hospital Manhasset /ID# 223343 - Manhasset

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2021-04-16
Est. Completion 2023-08-14
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04554966

The ClinicalTrials.gov registry entry for NCT04554966 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (89% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions - of which ABBV-382 is the first listed.

NCT04554966 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Texas, California.

Frequently Asked Questions

What is clinical trial NCT04554966 about?

NCT04554966 is a clinical study titled "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)". Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in a...

What is the current status of trial NCT04554966?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-04-16. Estimated completion is 2023-08-14.

What conditions does trial NCT04554966 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV).

What interventions are being tested in trial NCT04554966?

The interventions under investigation include: ABBV-382 (DRUG), Placebo for ABBV-382 (DRUG).

Who is sponsoring clinical trial NCT04554966?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04554966 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.