Status and phase
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Treatments
About
This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection. An initial "Sentinel Group" of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration and decreasing administration time until undiluted IV Push over 30 seconds is achieved, while safety and pharmacokinetics are evaluated. If no safety signals are seen, the Core Group of 15 participants will be enrolled. The Core Group will receive 800mg Trogarzo via undiluted IV Push over 30 seconds while safety and pharmacokinetics are monitored. After completion of the IV Push portion of the study, a second group of 20 participants will be enrolled to evaluate the safety and pharmacokinetics of administration of 800mg via intramuscular injection.
Full description
This goal of this Phase 3 is to evaluate the safety and pharmacokinetics of administering Trogarzo 800 mg once every two weeks as an undiluted IV Push over 30 seconds, and as an intramuscular injection in clinically stable HIV-1 infected patients currently receiving treatment with a stable Trogarzo-containing regimen and in healthy volunteers.
The first five (5) patients enrolled will comprise the Sentinel Group. Patients six (6) through twenty (20) (the Core Group) will not be screened until the Sentinel Group has completed Day 99 (14 weeks) of the study and the DSMB has reviewed the data accumulated and given approval for enrollment of the Core Group to proceed.
The Sentinel Group will receive 2 successive doses of Trogarzo in accordance with the prescribing information. Safety and pharmacokinetic data from these administrations will serve as the comparator for each study participant. Beginning at Day 29 and continuing through Day 85, Sentinel Group participants will begin receiving the prescribed dosage of Trogarzo once every two weeks through Day 85 of the study on a schedule of increasing drug concentration and decreasing administration time at each visit to achieve an undiluted IV Push administration of Trogarzo over 30 seconds.
After review of data from the Sentinel Group by a DSMB, if approved the study will continue with enrollment of the Core Group, which will enroll both clinically stable HIV-infected patients on a stable Trogarzo-containing treatment regimen and healthy volunteers. The HIV-infected participants in the Core Group will receive 2 successive doses of Trogarzo in accordance with the prescribing information. Safety and pharmacokinetic data from these administrations will serve as the comparator for each study participant. Thereafter, HIV-infected participants in the Core Group will receive the prescribed dosage of Trogarzo via undiluted IV Push over 30 seconds through Day 71 of the study.
Healthy Volunteers in the Core Group will receive a single loading dose of 2000mg of Trogarzo, followed by three successive doses of 800mg Trogarzo in accordance with the prescribing information in order to reach steady state before pharmacokinetic data for analysis are collected. Thereafter, Healthy Volunteers in the Core Group will follow the same schedule of drug administration and assessments as the HIV-infected participants in the Core Group.
HIV-infected participants in the Intramuscular Injection Group will receive 2 successive doses of Trogarzo in accordance with the prescribing information. Safety and pharmacokinetic data from these administrations will serve as the comparator for each study participant. Thereafter, HIV-infected Intramuscular Injection Group participants will receive the prescribed dosage of Trogarzo via intramuscular injection beginning at Day 29 and continuing through Day 71.
Healthy Volunteers in the Intramuscular Injection Group will receive a single loading dose of 2000mg of Trogarzo, followed by three successive doses of 800mg Trogarzo in accordance with the prescribing information in order to reach steady state before pharmacokinetic data for analysis are collected. Thereafter, Healthy Volunteers in the Intramuscular Injection Group will follow the same schedule of drug administration and assessments as the HIV-infected participants in the Intramuscular Injection Group.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria - HIV-infected participants (all groups):
Inclusion Criteria - Healthy Volunteers (all groups):
Volunteers born female with reproductive potential are defined as pre-menopausal volunteers born female who have not had a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). Volunteers born female are considered menopausal if they have not had a menses for at least 12 months and have a follicle-stimulating hormone (FSH) of greater than 40 IU/L or if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
Exclusion Criteria - HIV-infected participants (all groups):
Any active AIDS-defining illness according to the Centers for Disease Control and Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 (Morbidity and Mortality Weekly Report (MMWR) Vol.57/No. RR-10, Appendix A), or history of the same during the 3 months preceding Screening, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from Screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
Any significant acute illness within 1 week before the initial administration of study drug
Any active infection secondary to HIV requiring acute therapy; however, subjects that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study
Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment
Any vaccination within 7 days before Day 1
Any female subject who either is pregnant, intends to become pregnant, or is currently breastfeeding
Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the study schedule and protocol evaluations
Any radiation therapy during the 28 days before first administration of study medication
Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale, except for the following asymptomatic Grade 3 events:
History of coagulopathy that would preclude administration of IM injections (IM Group only)
Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site reactions (IM Group only)
Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole or other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only).
Exclusion Criteria - Healthy Volunteers (all groups):
Confirmed HIV-1 infection
At high risk of severe COVID-19 disease as defined by one of the following:
Any acute or chronic medical condition that in the opinion of the investigator would preclude participation
Chronic autoimmune disease
Active IV drug use
Excessive use of alcohol or recreational drugs that in the opinion of the investigator would preclude participation
Decompensated psychiatric illness
Need for chronic immunotherapy including systemic corticosteroids, other MAb therapy, or immunosuppressive drugs
Volunteers born female who are pregnant, lactating, or planning on becoming pregnant over the study period
Any of the following laboratory parameters:
Previous receipt of an experimental MAb for HIV-1treatment or prevention in a research study
History of severe allergic reactions to drugs, vaccines, or drug infusion
Participation in another investigational clinical trial within the past 12 weeks or anticipated during the course of the current study
History of coagulopathy that would preclude administration of IM injections (IM Group only)
Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site reactions (IM Group only)
Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamoleor any other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only).
Primary purpose
Allocation
Interventional model
Masking
46 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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