IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study
ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of North Carolina, Chapel Hill
About 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.
Eligibility criteria
Qualifiers
Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures
Able and willing to provide adequate locator information
Able and willing to comply with all study requirements through Day 28
Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans
Disqualifiers
Current use of moderate or strong CYP3A inhibitors or inducers for any indication including current use of a protease inhibitor, ritonavir, cobicistat, or efavirenz as part of ART regimen (See Section 6.1.1)
Significant history or presence of respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological disorders, immunodeficiency other than HIV-1, or clinical condition capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
Daily steroid or long-acting beta-agonist prevention
Hospitalization in the last two years
Trial design
Treatments tested in this trial
- IAP086 0.3 mcg/kg
- IAP086 1 mcg/kg
- IAP086 3 mcg/kg
- IAP086 6 mcg/kg
- IAP086 10 mcg/kg
- IAP086 15 mcg/kg
- IAP086 25 mcg/kg
- IAP086 32 mcg/kg
- IAP086 40 mcg/kg
Treatment groups
30 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov