30 Participants NeededMy employer runs this trial

IAP086 for HIV

Recruiting at 1 trial location
SP
Overseen BySusan Pedersen
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of North Carolina, Chapel Hill
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment, IAP086, for individuals living with HIV who are already managing their condition with stable antiretroviral therapy (ART). Participants will receive a one-time infusion of IAP086 and undergo close monitoring, starting with a low dose and increasing it as long as no concerning side effects appear. The trial suits those who have maintained well-controlled HIV with ART for at least two years and have kept their viral load very low during that time. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

No, you do not have to stop taking your current HIV medications. The trial requires you to continue your standard ART regimen throughout the study.

Is there any evidence suggesting that IAP086 is likely to be safe for humans?

Research shows that IAP086 is being tested for safety in people with well-controlled HIV. In earlier studies, participants received one infusion of IAP086 and experienced only minor side effects. The goal is for the treatment to remain safe and manageable, even as doses increase. Since this trial is in an early stage, the researchers are still gathering safety information, but no major issues have emerged so far. Participants will continue to be monitored for any signs or symptoms that might suggest side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about IAP086 for HIV because it represents a novel approach compared to existing treatments. Unlike standard antiretroviral therapies that suppress the virus, IAP086 is designed to potentially disrupt the virus's ability to integrate into host cells, offering a new mechanism of action. Additionally, IAP086 is administered as a single IV infusion, which could simplify treatment regimens and improve patient compliance compared to daily oral medications. If successful, it might provide a more efficient and potentially faster-acting alternative for managing HIV.

What evidence suggests that IAP086 might be an effective treatment for HIV?

Research shows that the treatment IAP086 remains in the early testing phase. Currently, limited information exists on its effectiveness for people with HIV. The trial's main goal is to determine its safety and tolerability. Participants will receive different dosages of IAP086 in separate cohorts to assess these factors. Some studies have found that other HIV treatments can reduce the virus to very low levels, offering hope that new treatments like IAP086 might also help manage HIV in the future. However, further testing is needed to understand its efficacy.12367

Who Is on the Research Team?

CG

Cynthia Gay, MD

Principal Investigator

UNC Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults aged 18–70 living with HIV who have been on stable HIV treatment (ART) and have had very low or undetectable virus levels in their blood for at least a year. Participants must be able to follow study procedures and not join other drug studies during this time.

Inclusion Criteria

Able and willing to provide informed consent and comply with study procedures
Able and willing to provide adequate locator information
Able and willing to comply with all study requirements through Day 28
See 21 more

Exclusion Criteria

QTc >450 msec at screening
History of coagulopathy or bleeding disorder or current/anticipated need for chronic anticoagulation
History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV infusion of IAP086 and are monitored for safety and tolerability

1 day
Overnight stay in research unit

Safety Monitoring

Participants are monitored for safety for 6 days following the study drug administration

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days
Visits on Days 2, 3, 7, 14, 21, and 28

What Are the Treatments Tested in This Trial?

Interventions

  • IAP086

Trial Overview

The study tests different single doses of a new medicine called IAP086, given by IV infusion, to see if it's safe for people with well-controlled HIV. All participants continue their usual HIV meds. The dose increases gradually as safety is confirmed.

How Is the Trial Designed?

9

Treatment groups

Experimental Treatment

Group I: Cohort 9Experimental Treatment1 Intervention
Group II: Cohort 8Experimental Treatment1 Intervention
Group III: Cohort 7Experimental Treatment1 Intervention
Group IV: Cohort 6Experimental Treatment1 Intervention
Group V: Cohort 5Experimental Treatment1 Intervention
Group VI: Cohort 4Experimental Treatment1 Intervention
Group VII: Cohort 3Experimental Treatment1 Intervention
Group VIII: Cohort 2Experimental Treatment1 Intervention
Group IX: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Citations

IAP-086-1: A Phase 1 Single Ascending Dose First-Time in ...

This outcome measures the number of Grade 3 or Greater (Severe) Adverse Events (AEs) that will be collected from treatment initiation through ...

IAP086 for HIV · Info for Participants

This trial is for adults aged 18–70 living with HIV who have been on stable HIV treatment (ART) and have had very low or undetectable virus ...

A Phase 1 Single Ascending Dose First-Time in Human Study

Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC ...

A Retrospective Population-Based Cohort Study - PMC

There were 335 HIV infections (92.9% effectiveness) over median cohort follow-up of 1.0 years (IQR 1.9) with 4.89 (95% CI 4.38, 5.44) HIV infections per 100 ...

"What excites me most about this work is that we're not only ...

Side effects are minimal for most people. Life expectancy for someone who starts treatment early and stays in care is close to that of someone ...

Gay Leads New Frontier in HIV Cure Science

The second, is testing a brand‑new drug (IAP 086) with a novel mechanism designed to awaken the hidden HIV reservoir. Cindy-Gay-David-Margolis ...

Safety and biologic activity of a bispecific T cell receptor ... - PMC

Data indicate mean ± SD infected cell elimination values obtained with purified CD8 + T cell effectors from 4 HIV-negative donors. c Potential ...