Clinical trial NCT04223804: A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
HIV Infection
HIV-1
Keywords: Human Immunodeficiency Virus (HIV)
HIV Infection
HIV-1
ABBV-181
Analytical Treatment Interruption
Budigalimab
Programmed cell death protein-1 (PD-1)
Anti-PD-1 Antibody
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher
timeFrame: Up to approximately 44 weeks
measure: Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)
timeFrame: Up to approximately 44 weeks
measure: Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome
timeFrame: Up to approximately 44 weeks
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to approximately 36 weeks
measure: Time to Cmax (Tmax)
timeFrame: Up to approximately 36 weeks
measure: Observed Concentration (Ctrough)
timeFrame: Up to approximately 36 weeks
measure: Area Under the Curve (AUCtau)
timeFrame: Up to approximately 36 weeks
measure: Half-life (t1/2)
timeFrame: Up to approximately 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta, Md /Id# 215721
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group /ID# 224866
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research /ID# 215796
state: California
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates /ID# 213893
state: District of Columbia
city: Fort Pierce
country: United States
facility: Midway Immunology and Research /ID# 215587
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine /ID# 213833
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center /ID# 243276
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute /ID# 224863
state: Florida
city: Berkley
country: United States
facility: Be Well Medical Center /ID# 223841
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 217820
state: Minnesota
city: Newark
country: United States
facility: Saint Michael's Medical Center /ID# 228733
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 215615
state: Ohio
city: Dallas
country: United States
facility: Prism Health North Texas - Oak Cliff Health Center /ID# 214036
state: Texas
city: Dallas
country: United States
facility: North TX Infectious Diseases /ID# 224861
state: Texas
city: Seattle
country: United States
facility: Peter Shalit, M.D. /ID# 224870
state: Washington
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice /ID# 215352
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney /ID# 215354
state: New South Wales
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 215351
state: Victoria
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 218083
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital /ID# 218082
state: Ontario
city: Montreal
country: Canada
facility: McGill Univ Clinical Research /ID# 218081
state: Quebec
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 218821
city: San Juan
country: Puerto Rico
facility: Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: