Ibalizumab for HIV Infection

(PROMISE-US Trial)

Not currently recruiting at 46 trial locations

Overseen By Nathalie Turgeon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Theratechnologies

Must be taking: Antiretrovirals

Disqualifiers: Pregnant, Breastfeeding, Hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of ibalizumab, used with other antiretrovirals (ARVs), for individuals with tough-to-treat, drug-resistant HIV. The goal is to determine if ibalizumab helps control the virus and is safe for long-term use. Participants are divided into two groups: one using ibalizumab and one not, to compare outcomes. Individuals with HIV who have tried many treatments without success and have drug-resistant HIV might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. It seems you may continue your existing antiretroviral treatments, as the study involves adding ibalizumab to your regimen.

What is the safety track record for ibalizumab?

Research has shown that ibalizumab is generally safe and well-tolerated. In studies, patients reported no serious side effects from using ibalizumab. Over 48 weeks, participants experienced no severe negative reactions. Additionally, ibalizumab is approved for use with other HIV treatments, indicating a certain level of safety. However, due to the limited number of long-term studies, ongoing safety checks remain important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Ibalizumab is unique because it works differently from other HIV treatments. While most drugs target the virus directly, ibalizumab is a monoclonal antibody that blocks the virus from entering human cells, offering a fresh approach for patients with multidrug-resistant HIV. Researchers are excited about ibalizumab because it provides hope for those who have limited options due to drug resistance, potentially transforming the management of this challenging condition.

What is the effectiveness track record for ibalizumab in treating HIV?

Research has shown that ibalizumab effectively treats HIV that resists many other drugs. In one study, patients taking ibalizumab experienced a significant drop in the virus in their blood, with an average decrease by week 25. Another study found that 44% of patients on a specific dose of ibalizumab had no detectable virus in their blood. Ibalizumab prevents the virus from entering the immune cells it typically infects. In this trial, participants in Cohort 2 will receive ibalizumab as part of their treatment regimen. Additionally, patients on ibalizumab have lived longer compared to those not taking it. These findings suggest that ibalizumab is a promising option for people with limited treatment choices. ^{1 4 6 7 8}

Who Is on the Research Team?

Princy N Kumar, MD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient is Heavily treatment-experienced (HTE), with limited treatment options and a history of treatment failure;

Received an appropriate HIV-1 resistance assay (genotypic or phenotypic testing) to devise an OBR (which may include an investigational ARV treatment) or will receive an appropriate resistance assay prior to initiating ibalizumab treatment;

Provide signed and dated informed consent to the Investigator, indicating that the patient (or, legally acceptable representative) has been informed of all pertinent aspects of the study, and is capable of understanding and willing to comply with the registry requirements. The consent will request to access the patient's medical, hospital, pharmacy, and vital statistics records as appropriate, as well as historical medical data for the full retrospective time period (01 May 2018 to enrollment). Further, consent will be provided for access to all available historical resistance and ARV treatment data;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-ibalizumab treatment

Heavily treatment-experienced patients with MDR HIV not receiving ibalizumab are monitored and may roll-over into ibalizumab treatment if their regimen changes.

Variable

Ibalizumab treatment

Patients start treatment with an ARV regimen that includes ibalizumab. Monitoring includes CD4 count, viral load, weight, and adverse reactions.

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient experience with IV administration.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ibalizumab

How Is the Trial Designed?

Group I: Cohort 2 (On ibalizumab treatment): Experimental Treatment 1 Intervention

This cohort will be comprised of Heavily Treatment-Experienced patients (HTE) with Multi Drug Resistant (MDR) HIV who are starting treatment with an ARV regimen that includes ibalizumab. Patients already receiving ibalizumab prior to study entry may also be included in Cohort 2 if baseline viral load (VL) and cluster of differentiation 4 (CD4) count data are available prior to ibalizumab treatment. Recruited patients will be required to consent to provide their full retrospective ARV treatment and drug resistance history, as well as retrospective historical data from their medical records from 01 May 2018 to enrollment.

Group II: Cohort 1 (No ibalizumab or Pre-ibalizumab treatment): Experimental Treatment 1 Intervention

This cohort will be comprised of Heavily treatment-experienced (HTE) patients with Multi Drug Resistant (MDR) HIV who are not receiving ibalizumab. These patients will roll-over into cohort 2 if a change to their ARV regimen is made to include ibalizumab.

Who Is Running the Clinical Trial?

Theratechnologies

Lead Sponsor

Trials

11

Recruited

1,900+

Excelsus Statistics Inc.

Collaborator

Trials

1

Recruited

200+

Health Psychology Research Group (HPR)

Collaborator

Trials

1

Recruited

200+

ICON Clinical Research

Industry Sponsor

Trials

52

Recruited

15,100+

Research Organization (KC) Ltd.

Collaborator

Trials

1

Recruited

200+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39250331/

Efficacy and Safety of 2 Fixed Doses of Ibalizumab Plus ...

Results: Viral loads (VL) below the detection limit were achieved in 44% and 28% of patients in the 800 mg q2wk and 2000 mg q4wk groups, ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1711460

Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1

At week 25, patients who had received ibalizumab plus an optimized background regimen had a mean decrease of 1.6 log10 copies per milliliter ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02707861

Study Details | NCT02707861 | Ibalizumab Plus Optimized ...

Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.

4.

valueinhealthjournal.com

valueinhealthjournal.com/article/S1098-3015(18)30362-0/fulltext

Long-Term Health Benefit of Ibalizumab In The Treatment ...

Compared with individuals receiving OBT alone, the model showed that individuals treated with ibalizumab+OBT experienced 0.77 more life years (9% improvement) ...

5.

emjreviews.com

emjreviews.com/microbiology-infectious-diseases/symposium/ibalizumabs-role-in-multidrug-resistant-hiv-j100124/

Ibalizumab's Role in Multidrug-Resistant HIV

This 3-year, real-world study will investigate long-term efficacy and durability of ibalizumab plus an OBR (IBA group), compared to matched ...

6.

trogarzo.com

trogarzo.com/hcp/isi/

Important Safety Information

TROGARZO® (ibalizumab‑uiyk), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7899216/

Efficacy, Pharmacokinetics, and Safety Over 48 Weeks ...

CD4+ T cell counts increased significantly by week 48 in both arm A and arm B, relative to placebo. No ibalizumab-related serious adverse events were reported.

8.

clinicalinfo.hiv.gov

clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/ibalizumab

Pediatric Antiretroviral Drug Information - Ibalizumab | NIH

Forty-eight-week safety and efficacy on-treatment analysis of ibalizumab in patients with multi-drug resistant HIV-1. Open Forum Infect Dis. 2017;4(Suppl 1): ...