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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04223804
Other study ID # M19-939
Secondary ID 2019-004866-16
Status Completed
Phase Phase 1
First received
Last updated
Start date January 30, 2020
Est. completion date February 27, 2023

Study information

Verified date March 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 27, 2023
Est. primary completion date February 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Body Mass Index (BMI) between 18.0 and 35 kg/m2. - HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening. - Meets HIV-specific laboratory parameters as below: - Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening. - CD4+ T cell count >= 500 cells/uL at screening and at least once during the 12 months prior to screening. - CD4+ T cell nadir of >= 200 cells/uL during chronic infection. - Willing to undergo ART interruption. - Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study. Exclusion Criteria: - Known resistance to at least 2 classes of ART. - History of AIDS-defining illness. - Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years. - History of or active immunodeficiency (other than HIV). - Active autoimmune disease or history of autoimmune disease that has required systemic treatment. - Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug. - Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor. - Current hepatitis B virus or hepatitis C virus infection. - Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)). - Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements. - Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABBV-181
Intravenous (IV) Infusion
Placebo
Intravenous (IV) infusion

Locations

Country Name City State
Australia Holdsworth House Medical Practice /ID# 215352 Darlinghurst New South Wales
Australia St Vincent's Hospital Sydney /ID# 215354 Darlinghurst New South Wales
Australia The Royal Melbourne Hospital /ID# 215351 Parkville Victoria
Canada McGill Univ Clinical Research /ID# 218081 Montreal Quebec
Canada Ottawa Hospital Research Institute /ID# 218083 Ottawa Ontario
Canada Toronto General Hospital /ID# 218082 Toronto Ontario
Puerto Rico Clinical Research Puerto Rico /ID# 218821 San Juan
Puerto Rico Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761 San Juan
United States Franco Felizarta, Md /Id# 215721 Bakersfield California
United States Be Well Medical Center /ID# 223841 Berkley Michigan
United States University of Cincinnati /ID# 215615 Cincinnati Ohio
United States North TX Infectious Diseases /ID# 224861 Dallas Texas
United States Prism Health North Texas - Oak Cliff Health Center /ID# 214036 Dallas Texas
United States Midway Immunology and Research /ID# 215587 Fort Pierce Florida
United States Ruane Clinical Research Group /ID# 224866 Los Angeles California
United States University of Miami, Miller School of Medicine /ID# 213833 Miami Florida
United States Saint Michael's Medical Center /ID# 228733 Newark New Jersey
United States Orlando Immunology Center /ID# 243276 Orlando Florida
United States Mayo Clinic - Rochester /ID# 217820 Rochester Minnesota
United States Quest Clinical Research /ID# 215796 San Francisco California
United States Peter Shalit, M.D. /ID# 224870 Seattle Washington
United States George Washington University Medical Faculty Associates /ID# 213893 Washington District of Columbia
United States Triple O Research Institute /ID# 224863 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher 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 44 weeks
Primary 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 NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale. Up to approximately 44 weeks
Primary Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome. Up to approximately 44 weeks
Primary Maximum Observed Concentration (Cmax) Maximum Observed Concentration (Cmax) of ABBV-181. Up to approximately 36 weeks
Primary Time to Cmax (Tmax) Time to Cmax (Tmax) of ABBV-181. Up to approximately 36 weeks
Primary Observed Concentration (Ctrough) Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181. Up to approximately 36 weeks
Primary Area Under the Curve (AUCtau) Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181. Up to approximately 36 weeks
Primary Half-life (t1/2) Half-life (t1/2) of ABBV-181 following the last dose. Up to approximately 36 weeks
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