A Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

  • STATUS
    Recruiting
  • End date
    Apr 22, 2022
  • participants needed
    40
  • sponsor
    AbbVie
Updated on 15 September 2021
body mass index
immunodeficiency
antiretroviral
antiretroviral agents
antiretroviral therapy
HIV Vaccine
drug test
hiv-1 rna measurement

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.

Details
Condition HIV, HIV infection, HIV-1, Immunodeficiency, Primary Immunodeficiency Disorders, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease
Treatment Placebo, ABBV-181
Clinical Study IdentifierNCT04223804
SponsorAbbVie
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Body Mass Index (BMI) >= 18.0 to <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 >= 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 6 months 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note