HIV-1-infectionPhase 3NCT03913195
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
A Phase 3 study testing ibalizumab-uiyk in people with HIV-1-infection, run by TaiMed Biologics Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- ibalizumab-uiyk
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 May 2019to 31 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers born male and female as assessed by medical history and physical examination
- Aged >18 and <50 years at the time of Screening
- Ability and willingness to provide written informed consent
- Willingness to comply with protocol schedule
- Willingness to undergo HIV-1 testing
- Non-reactive 4th generation point of care HIV-1 test at Screening
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- Hepatitis B Surface antigen negative
- Hepatitis C antibody negative, or if reactive, Hepatitis C RNA undetectable in plasma
- PT and PTT <1.5 times the upper limit of normal (IM Group only)
- Volunteers born female of reproductive potential who are sexually active with a male sex partner must agree to use one effective method of contraception from the time of signing the consent to completion of the study and agree to pregnancy testing as per the schedule of events.
- 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:
- triglyceride elevation
- total cholesterol elevation
- or Grade 3 or 4 reductions in levels of CD4+ T cells
- 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).
Who cannot join
- Confirmed HIV-1 infection
- At high risk of severe COVID-19 disease as defined by one of the following:
- History of hypertension, atherosclerotic cardiovascular disease (ASCVD), coronary artery disease, diabetes mellitus
- History of asthma or chronic pulmonary disease
- History of renal disease and chronic renal insufficiency
- BMI over 35
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- 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 monoclonal antibody (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:
- Hemoglobin <10.0 g/dL
- Absolute neutrophil count <1,000/mm3
- Absolute lymphocyte count <500/mm3
- Platelet count <100,000/mm3
- Creatinine >1.25x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >1.5x ULN
- Alanine aminotransferase (ALT) >1.5x ULN
- Glucose (non-fasting) >160 mg/dL
- Proteinuria: 2+ or greater
- Hematuria: >10 red blood cells (RBCs) per high-power field
- 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, dipyridamole any other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Gary Richmond MD, PA
Fort Lauderdale, Florida, 33316
Anthony Mills MD Inc.
Los Angeles, California, 90069
Orlando Immunology Center
Orlando, Florida, 32803
About this study
Official title: A Phase 3 Study of the Safety of Trogarzo® Administered as an Undiluted "IV Push" Over a Reduced Interval or as an Intramuscular Injection in Clinically Stable HIV-1 Infected Trogarzo® Experienced Patients and Healthy HIV-uninfected Volunteers
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.
Read the detailed 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 Data Safety Monitoring Board (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.
- Conditions
- HIV-1-infection
- Being tested
- ibalizumab-uiyk
- Keywords
- HIV, ibalizumab, Multi-drug Resistant (MDR) HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibalizumab-uiykDrug
Also called Trogarzo
Ibalizumab-uiyk is an Immunoglobulin G4 (IgG4) monoclonal antibody targeting domain 2 of the extracellular portion of the Cluster of Differentiation 4 (CD4) protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Group-HIV + | Experimental | Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time. Receives: Drug: ibalizumab-uiyk |
| Core Group- HIV+ | Experimental | HIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Receives: Drug: ibalizumab-uiyk |
| Core Group-HIV uninfected | Experimental | Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. Receives: Drug: ibalizumab-uiyk |
| Intramuscular Injection Group-HIV+ | Experimental | HIV+ participants in this group will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. Receives: Drug: ibalizumab-uiyk |
| Intramuscular Injection Group-HIV uninfected | Experimental | Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. Receives: Drug: ibalizumab-uiyk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Trogarzo Given as IV Push Over 30 Seconds
Number of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Measured: 12 weeks
Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus IV push (IVP) over 30 seconds
Measured: Day 1 infusion versus Day 85 IV Push
Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)
Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
Measured: Day 1 infusion versus Day 85 IV Push
Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group
Number of subjects in Intramuscular Injection Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Measured: 10 weeks
Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus intramuscular (IM) injection
Measured: Day 1 infusion versus Day 71 intramuscular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start30 May 2019
- Primary completion17 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Westat
- Responsible party
- Sponsor
- Investigators
- Martin Markowitz, MD, Study chair, TaiMed Biologics Inc. - Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913195
- Sponsor's protocol ID
- TMB-302
- Status last verified
- Oct 2025
- First submitted
- 9 Apr 2019
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of the Safety of Trogarzo® Administered as an Undiluted "IV Push" Over a Reduced Interval or as an Intramuscular Injection in Clinically Stable HIV-1 Infected Trogarzo® Experienced Patients and Healthy HIV-uninfected Volunteers
- ClinicalTrials.gov ID
- NCT03913195
- Acronym / sponsor ID
- TMB-302
- Conditions
- HIV-1-infection
- Keywords
- HIV, ibalizumab, Multi-drug Resistant (MDR) HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Westat
- Study start
- 30 May 2019 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 Data Safety Monitoring Board (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sentinel Group-HIV + | Experimental | Drug: ibalizumab-uiykFive (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time. |
| Core Group- HIV+ | Experimental | Drug: ibalizumab-uiykHIV-infected Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. |
| Core Group-HIV uninfected | Experimental | Drug: ibalizumab-uiykHealthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds. |
| Intramuscular Injection Group-HIV+ | Experimental | Drug: ibalizumab-uiykHIV+ participants in this group will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. |
| Intramuscular Injection Group-HIV uninfected | Experimental | Drug: ibalizumab-uiykHealthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Healthy volunteers born male and female as assessed by medical history and physical examination
- Aged >18 and <50 years at the time of Screening
- Ability and willingness to provide written informed consent
- Willingness to comply with protocol schedule
- Willingness to undergo HIV-1 testing
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibalizumab-uiykAlso: TrogarzoIbalizumab-uiyk is an Immunoglobulin G4 (IgG4) monoclonal antibody targeting domain 2 of the extracellular portion of the Cluster of Differentiation 4 (CD4) protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients. | Drug | Core Group- HIV+, Core Group-HIV uninfected, Intramuscular Injection Group-HIV uninfected, Intramuscular Injection Group-HIV+, Sentinel Group-HIV + |
Primary outcome
Safety of Trogarzo Given as IV Push Over 30 Seconds
Time frame: 12 weeks
Number of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)
Time frame: Day 1 infusion versus Day 85 IV Push
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus IV push (IVP) over 30 seconds
Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)
Time frame: Day 1 infusion versus Day 85 IV Push
Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group
Time frame: 10 weeks
Number of subjects in Intramuscular Injection Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion
Time frame: Day 1 infusion versus Day 71 intramuscular injection
Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus intramuscular (IM) injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Markowitz, MD study chair
TaiMed Biologics Inc. - Consultant
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibalizumab-uiyk in people with HIV-1-infection, run by TaiMed Biologics Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Trogarzo Given as IV Push Over 30 Seconds (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.