Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push"

• Status: Completed
• Trial end date: 2021-07-05
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push". 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiMed Biologics Inc.
• Collaborator: Westat
• Treatments: Antibodies, Monoclonal; Ibalizumab

Criteria

Inclusion Criteria:

1. Are capable of understanding and have voluntarily signed the informed consent document

2. Currently receiving a stable Trogarzo-containing 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

3. 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

4. Are able and willing to comply with all protocol requirements and procedures

5. Are 18 years of age or older

6. Have a life expectancy that is >6 months.

7. Have a viral load <1,000 copies/mL at Screening

8. CD4+ T-cell count > 50 cells/mm3 at Screening

Exclusion Criteria:

1. Any active AIDS-defining illness according to the Centers for Disease Control and Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 (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

2. 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 patient from participating in this study

3. Any significant acute illness within 1 week before the initial administration of study drug

4. Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study.

5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment

6. Any vaccination within 7 days before Day 1

7. Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding

8. Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations

9. Any radiation therapy during the 28 days before first administration of study medication

10. Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS grading scale, except for the following asymptomatic Grade 3 events:

• triglyceride elevation

• total cholesterol elevation any Grade 3 or 4 reduction in CD4+ T cell counts