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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ABBV-382 Dose A | Experimental | Participants will receive intravenous (IV) ABBV-382 dose A on Day 1. |
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| Part A: ABBV-382 Dose B | Experimental | Participants will receive intravenous (IV) ABBV-382 dose B on Day 1. |
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| Part B: Intravenous Cohort: ABBV-382 Dose A | Experimental | Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57. |
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| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A | Placebo Comparator | Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57. |
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| Part B: Intravenous Cohort: ABBV-382 Dose B | Experimental | Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57. |
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| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-382 | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Study Drug-Related Grade 3 or Higher Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either "Reasonable Possibility" or "No Reasonable Possibility" and will assess the severity of each adverse event from Grade 1 (mild) to Grade 4 (potentially life-threatening). | Up to Day 255 |
| Maximum Observed Serum Concentration (Cmax) of ABBV-382 (Part A and Part B) | Maximum observed serum concentration (Cmax) of ABBV-382. | Up to Day 225 |
| Time to Cmax (Tmax) of ABBV-382 (Part A and Part B) | Time to Cmax (Tmax) of ABBV-382. | Up to Day 225 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A) | Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382. | Up to Day 112 |
| Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A) | AUC from time 0 to infinite time (AUCinf) of ABBV-382. | Up to Day 112 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A) | Terminal phase elimination rate constant of ABBV-382. | Up to Day 112 |
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Inclusion Criteria:
Part A participants must also have:
Part B participants must also have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franco Felizarta, Md /Id# 223815 | Bakersfield | California | 93301 | United States | ||
| Ruane Clinical Research Group /ID# 224125 |
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Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57. |
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| Part B: Subcutaneous Cohort: ABBV-382 | Experimental | Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57. |
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| ABBV-382 | Drug | Subcutaneous (SC) injection |
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| Placebo for ABBV-382 | Drug | Intravenous (IV) infusion |
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| Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A) | Terminal phase elimination half-life of ABBV-382. | Up to Day 112 |
| Observed Concentration at the End of the 4-Week Dosing Interval (Ctrough) of ABBV-382 (Part B) | Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382. | Up to Day 225 |
| AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B) | AUC during the 4-week dosing interval (AUCtau) of ABBV-382. | Up to Day 225 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part B) | Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only. | Day 57 to Day 225 |
| Los Angeles |
| California |
| 90036 |
| United States |
| Quest Clinical Research /ID# 223347 | San Francisco | California | 94115-3037 | United States |
| George Washington University Medical Faculty Associates /ID# 223493 | Washington D.C. | District of Columbia | 20037-3201 | United States |
| Midway Immunology and Research Center /ID# 223500 | Ft. Pierce | Florida | 34982 | United States |
| Orlando Immunology Center /ID# 223498 | Orlando | Florida | 32803 | United States |
| St. Joseph Comprehensive Research Institute /ID# 246232 | Tampa | Florida | 33614-7112 | United States |
| Triple O Research Institute /ID# 223460 | West Palm Beach | Florida | 33407-3100 | United States |
| CenExcel iResearch LLC /ID# 225526 | Decatur | Georgia | 30030 | United States |
| Infinite Clinical Trials - Morrow /ID# 225455 | Morrow | Georgia | 30260-2342 | United States |
| University of Iowa Hospitals and Clinics /ID# 224267 | Iowa City | Iowa | 52242 | United States |
| Be Well Medical Center /ID# 223381 | Berkley | Michigan | 48072-3046 | United States |
| North Shore University Hospital Manhasset /ID# 223343 | Manhasset | New York | 11030-3816 | United States |
| The Christ Hospital /ID# 224871 | Cincinnati | Ohio | 45219 | United States |
| Central Texas Clinical Research /ID# 223378 | Austin | Texas | 78705-3326 | United States |
| Prism Health North Texas - Oak Cliff Health Center /ID# 223237 | Dallas | Texas | 75208-4599 | United States |
| North Texas Infectious Diseases Consultants, P.A /ID# 223236 | Dallas | Texas | 75246 | United States |
| The Crofoot Research Center, Inc /ID# 223383 | Houston | Texas | 77098-3900 | United States |
| Peter Shalit, M.D. /ID# 224252 | Seattle | Washington | 98104-3595 | United States |
| Ponce Medical School Foundation /ID# 224231 | Ponce | 00716-0377 | Puerto Rico |
| Clinical Research Puerto Rico /ID# 223923 | San Juan | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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