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)
Public ClinicalTrials.gov record NCT04554966. 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 Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ABBV-382 in Persons Living With HIV-1 (PLWH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04554966
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 54 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
- Apr 15, 2021
- Primary completion
- Aug 13, 2023
- Completion
- Aug 13, 2023
- Last update posted
- Mar 3, 2024
2021 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Franco Felizarta, Md /Id# 223815 | Bakersfield | California | 93301 | — |
| Ruane Clinical Research Group /ID# 224125 | Los Angeles | California | 90036 | — |
| Quest Clinical Research /ID# 223347 | San Francisco | California | 94115-3037 | — |
| George Washington University Medical Faculty Associates /ID# 223493 | Washington D.C. | District of Columbia | 20037-3201 | — |
| Midway Immunology and Research Center /ID# 223500 | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center /ID# 223498 | Orlando | Florida | 32803 | — |
| St. Joseph Comprehensive Research Institute /ID# 246232 | Tampa | Florida | 33614-7112 | — |
| Triple O Research Institute /ID# 223460 | West Palm Beach | Florida | 33407-3100 | — |
| CenExcel iResearch LLC /ID# 225526 | Decatur | Georgia | 30030 | — |
| Infinite Clinical Trials - Morrow /ID# 225455 | Morrow | Georgia | 30260-2342 | — |
| University of Iowa Hospitals and Clinics /ID# 224267 | Iowa City | Iowa | 52242 | — |
| Be Well Medical Center /ID# 223381 | Berkley | Michigan | 48072-3046 | — |
| North Shore University Hospital Manhasset /ID# 223343 | Manhasset | New York | 11030-3816 | — |
| The Christ Hospital /ID# 224871 | Cincinnati | Ohio | 45219 | — |
| Central Texas Clinical Research /ID# 223378 | Austin | Texas | 78705-3326 | — |
| Prism Health North Texas - Oak Cliff Health Center /ID# 223237 | Dallas | Texas | 75208-4599 | — |
| North Texas Infectious Diseases Consultants, P.A /ID# 223236 | Dallas | Texas | 75246 | — |
| The Crofoot Research Center, Inc /ID# 223383 | Houston | Texas | 77098-3900 | — |
| Peter Shalit, M.D. /ID# 224252 | 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04554966, 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 3, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04554966 live on ClinicalTrials.gov.