Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT04554966 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2023-08-14 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04554966 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04554966?
The interventions under investigation include: ABBV-382 (DRUG), Placebo for ABBV-382 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04554966?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.