IAP086 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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 within 18 to 70years of age. People with HIV on ART with plasma HIV-1 RNA \< 50 copies/mL for 12 months prior to screening.
Procedures (methods):
The participant's standard of care ART regimen is continued throughout the study period.
This study requires an overnight stay in a research unit. During the overnight stay, participants will receive a single infusion (medicine given slowly through a vein in their arm) of IAP086 and be monitored for 24 hours. Each later participant receives IAP086 at the same or a higher dose decided in advance. The dose will increase as more participants receive IAP086 without concerning side effects. Study visits also occur 2, 3, 7, 14, 21 and 28 days after the study drug is given. Study procedures include review of the medical history, physical exams, and blood draws.
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single IV infusion of IAP086 and are monitored for safety and tolerability
Safety Monitoring
Participants are monitored for safety for 6 days following the study drug administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Each participant will receive a single IV infusion of 40 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 32 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 25 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 15 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 10 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 6 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 3 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 1 mcg/kg IAP086 on Day 0.
Each participant will receive a single IV infusion of 0.3 mcg/kg IAP086 on Day 0.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.