A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
Public ClinicalTrials.gov record NCT04223804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.
Study identification
- NCT ID
- NCT04223804
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2020 (Actual)
- Primary completion
- Feb 27, 2023 (Actual)
- Completion
- Feb 27, 2023 (Actual)
- Last update posted
- Mar 9, 2023
2020 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Franco Felizarta, Md /Id# 215721 | Bakersfield | California | 93301 | — |
| Ruane Clinical Research Group /ID# 224866 | Los Angeles | California | 90036 | — |
| Quest Clinical Research /ID# 215796 | San Francisco | California | 94115-3037 | — |
| George Washington University Medical Faculty Associates /ID# 213893 | Washington D.C. | District of Columbia | 20037-3201 | — |
| Midway Immunology and Research /ID# 215587 | Ft. Pierce | Florida | 34982 | — |
| University of Miami, Miller School of Medicine /ID# 213833 | Miami | Florida | 33136 | — |
| Orlando Immunology Center /ID# 243276 | Orlando | Florida | 32803 | — |
| Triple O Research Institute /ID# 224863 | West Palm Beach | Florida | 33407-3100 | — |
| Be Well Medical Center /ID# 223841 | Berkley | Michigan | 48072-3046 | — |
| Mayo Clinic - Rochester /ID# 217820 | Rochester | Minnesota | 55905-0001 | — |
| Saint Michael's Medical Center /ID# 228733 | Newark | New Jersey | 07102 | — |
| University of Cincinnati /ID# 215615 | Cincinnati | Ohio | 45267-0585 | — |
| Prism Health North Texas - Oak Cliff Health Center /ID# 214036 | Dallas | Texas | 75208-4599 | — |
| North TX Infectious Diseases /ID# 224861 | Dallas | Texas | 75246 | — |
| Peter Shalit, M.D. /ID# 224870 | Seattle | Washington | 98104-3595 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04223804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2023 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04223804 live on ClinicalTrials.gov.