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This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.
Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.
Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks.
Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Placebo SC + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo. |
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| Group 2: Budigalimab (SC) + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
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| Group 3: Budigalimab SC + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
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| Group 4: Placebo SC + Budigalimab IV | Experimental | Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budigalimab | Drug | Subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing 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 the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE. | Up to approximately 24 weeks |
| Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE) | Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines [which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale. | Up to approximately 24 weeks |
| Maximum Serum Concentration (Cmax) | Maximum Serum Concentration (Cmax) of Budigalimab. | Up to approximately 24 weeks |
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab. | Up to approximately 24 weeks |
| Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma | Area Under the Plasma Concentration-time Curve (AUC). | Up to approximately 24 weeks |
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Inclusion Criteria:
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# 223931 | Bakersfield | California | 93301 | United States | ||
| Ruane Clinical Research Group /ID# 224496 |
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| Placebo | Drug | Subcutaneous (SC) |
|
| Budigalimab | Drug | Intravenous (IV) |
|
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| Placebo | Drug | Intravenous (IV) |
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| Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma |
Terminal phase elimination half-life (t1/2) |
| Up to approximately 24 weeks. |
| Los Angeles |
| California |
| 90036 |
| United States |
| Quest Clinical Research /ID# 223925 | San Francisco | California | 94115-3037 | United States |
| Central Texas Clinical Research /ID# 223937 | Austin | Texas | 78705-3326 | United States |
| St. Hope Foundation, Inc. /ID# 224492 | Bellaire | Texas | 77401-4528 | United States |
| North TX Infectious Diseases /ID# 224494 | Dallas | Texas | 75246 | United States |
| The Crofoot Research Center, Inc /ID# 224493 | Houston | Texas | 77098-3900 | United States |
| Peter Shalit, M.D. /ID# 224801 | Seattle | Washington | 98104-3595 | United States |
| Ponce Medical School Foundation /ID# 224230 | Ponce | 00716-0377 | Puerto Rico |
| Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936 | San Juan | 00935 | 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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| ID | Term |
|---|---|
| C000719868 | budigalimab |
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