Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injec… (NCT03913195) | Clinical Trial Compass
CompletedPhase 3
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
United States43 participantsStarted 2019-05-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Are capable of understanding and have voluntarily signed the informed consent document
âś“. Currently receiving a stable Trogarzo-containing antiretroviral (ARV) regimen for a minimum of 3 months, and no change in background ARVs anticipated over the period of study participation; a stable regimen is defined as having no changes in dose or frequency and no interruptions greater than or equal to 2 weeks during the 3 month period
âś“. Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
âś“. Are able and willing to comply with all protocol requirements and procedures
âś“. Are 18 years of age or older
âś“. Have a life expectancy that is \>6 months.
âś“. Have a viral load \<1,000 copies/mL at Screening
âś“. CD4+ T-cell count \> 50 cells/mm3 at Screening
Exclusion criteria
âś•
What they're measuring
1
Safety of Trogarzo Given as IV Push Over 30 Seconds
Timeframe: 12 weeks
2
Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)
Timeframe: Day 1 infusion versus Day 85 IV Push
3
Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)
Timeframe: Day 1 infusion versus Day 85 IV Push
4
Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group
Timeframe: 10 weeks
5
Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion
Timeframe: Day 1 infusion versus Day 71 intramuscular injection
. 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
âś•. 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
âś•. Any significant acute illness within 1 week before the initial administration of study drug
âś•. 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
âś•. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment
âś•. Any vaccination within 7 days before Day 1
âś•. Any female subject who either is pregnant, intends to become pregnant, or is currently breastfeeding
âś•. 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