HIV-1-infectionPhase 1NCT07596888
IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study
A Phase 1 study testing IAP086 0.3 mcg/kg, IAP086 1 mcg/kg and IAP086 3 mcg/kg in people with HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- IAP086 0.3 mcg/kg, IAP086 1 mcg/kg and IAP086 3 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent
- HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.
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- NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all Investigational New Drug (IND) studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.
- Plasma HIV-1 RNA viral load must meet the following conditions:
- < 50 copies/mL at 2 time points within 12 months prior to screening
- < 50 copies/mL at screening
- Not > 1000 copies/mL at any time within 6 months prior to screening
- On continuous ART for at least 24 months prior to screening and must continue ART throughout the study. Permitted ART regimens include:
- At least 3 ART drugs, one ART drug must include an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz excluded (see 5.2) or
- At least 2 ART drugs including injectables, in which one drug is an integrase inhibitor that is FDA approved or recommended by Department of Health and Human Services Treatment Guidelines.
- NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.
- NOTE: No changes or modifications of ART dosing allowed within 30 days prior to screening.
- CD4 cell count > 350 cells/mm3 at screening
- Hepatitis C virus (HCV) antibody negative or HCV RNA negative at screening
- Hepatitis B surface antigen negative at screening
- Clinical laboratory parameters obtained at screening as follows:
- Platelet count ≥ 125 × 103/µL
- Absolute neutrophil count ≥ 1.5 × 103/µL
- Absolute Lymphocyte levels ≥ 1000 cells/uL
- Hemoglobin ≥ 12 g/dL (male) and ≥ 11 g/dL (females)
- Prothrombin time or international normalized ratio (INR) ≤ 1.1 × upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 × ULN. If total bilirubin is elevated, direct bilirubin ≤ 2 × ULN. If ART includes atazanavir, direct bilirubin must be ≤ 1.0 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN
- Alkaline phosphatase (ALP) ≤ 1.5 × ULN
- Serum glucose (fasting or non-fasting) ≤ Grade 1
- Lipase ≤ 1.5 × ULN
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min as determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation (CKD-Epi equation) found at: https://www.mdcalc.com/calc/3939/ckd-epi-equations-glomerular-filtration-rate-gfr
- Negative serum pregnancy test for women of childbearing potential (WOCBP) with a sensitivity of at least 25 milli-International Units (mIU)/mL at screening
- All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) starting with screening visit through 30 days after receiving study drug
- WOCBP, defined as female at birth, is not pregnant, expecting to become pregnant, or breastfeeding or participant assigned male at birth is not expecting to father children, starting with screening visit through 30 days after receiving study product
- WOCBP, not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy), and not post-menopausal for at least 24 consecutive months, i.e., have had menses within the preceding 24 months, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug
- WOCBP and male participants of reproductive potential with WOCBP partners must agree to consistently use a highly effective method of contraception and a barrier method (condom, diaphragm or cervical cap) for the duration and for 30 days afterwards. Highly effective methods include the following:
- Highly effective methods include:
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Combined estrogen and progestogen oral contraceptive
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- True sexual abstinence (only if it is the participant's consistent lifestyle choice and not just trial-related).
- Sterilization of male partner with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for the participant. The documentation of partner sterility can come from the site personnel's review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.
- Barrier method may include:
- Male or female condoms with or without a cream or gel that kills sperm
- Diaphragm or cervical cap with a cream or gel that kills sperm
- Sponge
- Participants not of reproductive potential are eligible without requiring the use of contraceptives. Acceptable documentation are specified below.
- NOTE: Men who have sex with men only will not be required to use contraception NOTE: Women who have sex with women only will not be required to use contraception
- NOTE: Written/oral documentation communicated by clinician/clinician's staff of one of the following:
- Physician report/letter
- Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
- Discharge summary
- Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory
- Willingness to defer vaccinations, including influenza and Coronavirus Disease (COVID-19) vaccines, from 30 days prior to Day -1 through Day 28 post-infusion
- Willingness to abstain from alcohol, illicit drugs and grapefruit juice and limit caffeine intake from 24 hours prior to study treatment through Day 7
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
- Body mass index of less than 35
Who cannot join
- 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
- Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
- Daily steroid or long-acting beta-agonist prevention
- Hospitalization in the last two years
- Clinically significant cardiovascular disease within 12 months prior to screening including but not limited to:
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- Myocardial infarction or unstable angina
- Cardiac arrhythmias
- Uncontrolled hypertension at screening: systolic blood pressure > 180 mmHg, diastolic blood pressure >100 mmHg that is sustained on repeat measurement (without intervention)
- Cerebrovascular accident
- Congestive heart failure, New York Heart Association class II-IV
- QTc >450 msec at screening NOTE: QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read
- Diabetes mellitus ≥ Grade 3 per DAIDS criteria (defined as uncontrolled despite treatment modification or hospitalization for immediate glucose control indicated)
- History of malignancy within the last 3 years NOTE: History of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documentation of resolution per topical treatment or complete resection as determined by a dermatologist at least 3 months prior to screening
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral antibiotic, antiviral, or antifungal treatment within 14 days prior to the initiation of study drug.
- History of coagulopathy or other bleeding disorder or current or anticipated need for chronic anti-coagulation
- An underlying skin disease or disorder including, but not limited to, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria, or tattoo that would interfere with assessment of infusion sites
- History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis
- Use of any prescription or non-prescription drugs or dietary supplements that are prohibited (See Section 6.11), within 7 days prior to dosing
- Use of any immunosuppressive, immunomodulatory or cytokine therapy within 90 days prior to entry. Not Exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical steroids for mild, uncomplicated dermatitis unless it interferes with assessment of infusion site reactions; or [4] a single course of oral /parenteral prednisone or equivalent at doses <20mg/day and length of therapy <14 days with completion at least 30 days prior to enrollment.
- Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase II or higher studies of antiretroviral agents
- Regular use (daily to weekly) of known drugs of abuse within 3 months of enrollment
- Increased alcohol consumption within 6 months prior to screening, defined as an average weekly intake of >14 units for males or >7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Current tobacco use or current use of nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening
- Known sensitivity to any of the study interventions, or components thereof, or study drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
- Any other clinical condition, behavior or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
Susan Pedersen, 919-966-6713, susan_pedersen@med.unc.edu
Cynthia Gay, MD
- Recruiting
Duke Early Phase Clinical Research Unit
Durham, North Carolina, 27710
Shruti Raja, MD, shruti.raja@duke.edu
About this study
Official title: IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons With HIV-1 on Antiretroviral Therapy
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):
Read more
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.
Read the detailed description
This is a phase 1, open-label, dose-escalation, study of IAP086 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to characterize the safety, tolerability, and pharmacokinetics (PK) of the study drug in healthy PWH suppressed on ART. The participant's standard of care ART regimen is continued throughout the study period.
The study will evaluate single ascending doses of IAP086 with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9. Given the focus of this study is on safety, accrual within a dose cohort will be staggered such that each participant is followed for 6 days following study drug administration prior to study drug administration in a subsequent participant. A 14-day dose-limiting toxicity (DLT) period is observed prior to escalation to the next dose cohort level. Dose escalation proceeds until cell-associated HIV RNA induction (see below) or drug-related DLT criteria to halt escalation are met.
This study is designed to limit study drug exposures to participants due to the exploratory nature of this first-in-human study and effects seen after multiple doses in non-clinical toxicology studies. An adaptive dose escalation strategy will be used.
This study will have up to 9 dose cohorts starting at 0.3 µg/kg. Participants in each dose cohort will be dosed sequentially. Each participant will be directly monitored for safety for at least 24 hours after dosing, with a 6-day period of safety observations completed prior to dosing of the next participant in the same dose cohort.
The study will evaluate single ascending doses of IAP086 by intravenous (IV) infusion with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9.If no dose limiting toxicities occur in the 1 participant in cohorts 1-3 or 3 participants in cohorts 4-9, the study proceeds to the next higher dose following Safety Monitoring Committee (SMC) review.
All cohorts can be expanded to include an additional +3 participants if a treatment related DLT is observed to more fully explore safety events, clinical laboratory results, and virological or biomarker data prior to escalating to the next dose cohort.
- Conditions
- HIV-1-infection
- Being tested
- IAP086 0.3 mcg/kg, IAP086 1 mcg/kg, IAP086 3 mcg/kg, IAP086 6 mcg/kg, IAP086 10 mcg/kg
- Keywords
- HIV-1 on Antiretroviral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAP086 0.3 mcg/kgDrug
Single dose 0.3 mcg/kg IAP086 administered IV
IAP086 1 mcg/kgDrug
Single dose 1 mcg/kg IAP086 administered IV
IAP086 3 mcg/kgDrug
Single dose 3 mcg/kg IAP086 administered IV
IAP086 6 mcg/kgDrug
Single dose 6 mcg/kg IAP086 administered IV
IAP086 10 mcg/kgDrug
Single dose 10 mcg/kg IAP086 administered IV
IAP086 15 mcg/kgDrug
Single dose 15 mcg/kg IAP086 administered IV
IAP086 25 mcg/kgDrug
Single dose 25 mcg/kg IAP086 administered IV
IAP086 32 mcg/kgDrug
Single dose 32 mcg/kg IAP086 administered IV
IAP086 40 mcg/kgDrug
Single dose 40 mcg/kg IAP086 administered IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Each participant will receive a single IV infusion of 0.3 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 0.3 mcg/kg |
| Cohort 2 | Other | Each participant will receive a single IV infusion of 1 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 1 mcg/kg |
| Cohort 3 | Other | Each participant will receive a single IV infusion of 3 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 3 mcg/kg |
| Cohort 4 | Other | Each participant will receive a single IV infusion of 6 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 6 mcg/kg |
| Cohort 5 | Other | Each participant will receive a single IV infusion of 10 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 10 mcg/kg |
| Cohort 6 | Other | Each participant will receive a single IV infusion of 15 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 15 mcg/kg |
| Cohort 7 | Other | Each participant will receive a single IV infusion of 25 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 25 mcg/kg |
| Cohort 8 | Other | Each participant will receive a single IV infusion of 32 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 32 mcg/kg |
| Cohort 9 | Other | Each participant will receive a single IV infusion of 40 mcg/kg IAP086 on Day 0. Receives: Drug: IAP086 40 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment
Serious adverse events (SAEs) will be collected from treatment initiation through Day 28/end of study. SAEs are defined according to standard regulatory criteria (e.g., events that result in death, are life threatening, require or prolong hospitalization, result in persistent or significant disability/incapacity, or are otherwise medically important). This outcome includes only SAEs assessed by the study team as at least possibly related to study treatment (possibly or definitely related). Abnormal laboratory values or vital signs are included only if they meet SAE criteria. Non serious adverse events are summarized separately.
Measured: From first dose of study treatment through Day 28/end of study
Number of Grade 3 or Greater (Severe) Adverse Events (AEs) that are at least possibly related to study treatment
This outcome measures the number of Grade 3 or Greater (Severe) Adverse Events (AEs) that will be collected from treatment initiation through Day 28/end of study. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (The Division of AIDS (DAIDS) AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening.
Measured: From first dose of study treatment through Day 28/end of study
Number of Adverse Events (AEs) that are at least possibly related to study treatment
Adverse events (AEs) will be collected from treatment initiation through Day 28/end of study. AEs are defined according to standard regulatory criteria (e.g., any unfavorable, unintended medical occurrence (sign, symptom or disease) temporally associated with the use of the investigational product, regardless of whether it is considered related to the treatment. This outcome includes only AEs assessed by the study team at least possibly related to study treatment (possibly or definitely related) Non serious adverse events are summarized under overall safety/AE outcome.
Measured: From first dose of study treatment through Day 28/end of study
Proportion of participants who prematurely discontinue IAP086 study treatment due to Adverse Events (AEs) or Serious Adverse Events (SAEs) that are at least possibly related to study treatment
Safety data will include signs and symptoms, diagnoses, clinically significant laboratory abnormalities, and clinically significant abnormal vital signs that lead to premature discontinuation of study treatment. Relationship to study treatment will be assessed by the study team using the categories not related, possibly related, or definitely related. This outcome measure assesses the proportion of participants who permanently discontinue IAP086 study treatment due to an adverse event (AE) or serious adverse event (SAE) that is assessed as at least possibly related to study treatment. AEs and SAEs include clinical events, laboratory abnormalities, or abnormal vital signs that result in treatment discontinuation. Relationship to study treatment will be assessed by the study team as not related, possibly related, or definitely related.
Measured: From first dose of study treatment through Day 28/end of study
Secondary outcomes (5)
Mean Area Under the Concentration-time Curve (AUC)
Total body exposure to IAP086
Measured: Pre-infusion through 24-hours post-end of infusion
Mean Maximum Concentration (Cmax) of IAP086
The highest concentration of IAP086
Measured: Pre-infusion through 24-hours post-end of infusion
Mean Time to Maximal Concentration (Tmax) of IAP086
The amount of time required to reach maximum concentration of IAP086
Measured: Pre-infusion through 24-hours post-end of infusion
Mean Concentration at 24 hours post-IAP086 (C24)
The minimum concentration of IAP086
Measured: Pre-infusion through 24-hours post-end of infusion
Mean Terminal Half-life of IAP086
The amount of time needed for the body to clear half of the dose of IAP086
Measured: Pre-infusion through 24-hours post-end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label dose escalation design. Single Ascending Dose. Where the treatment dose is gradually increased in the cohorts
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Gay, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596888
- Sponsor's protocol ID
- 25-2299
- Status last verified
- Aug 2026
- First submitted
- 12 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study of the Safety, Tolerability and Pharmacokinetics of IAP086 in Persons With HIV-1 on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT07596888
- Acronym / sponsor ID
- 25-2299
- Conditions
- HIV-1-infection
- Keywords
- HIV-1 on Antiretroviral Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1, open-label, dose-escalation, study of IAP086 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to characterize the safety, tolerability, and pharmacokinetics (PK) of the study drug in healthy PWH suppressed on ART. The participant's standard of care ART regimen is continued throughout the study period.
The study will evaluate single ascending doses of IAP086 with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9. Given the focus of this study is on safety, accrual within a dose cohort will be staggered such that each participant is followed for 6 days following study drug administration prior to study drug administration in a subsequent participant. A 14-day dose-limiting toxicity (DLT) period is observed prior to escalation to the next dose cohort level. Dose escalation proceeds until cell-associated HIV RNA induction (see below) or drug-related DLT criteria to halt escalation are met.
This study is designed to limit study drug exposures to participants due to the exploratory nature of this first-in-human study and effects seen after multiple doses in non-clinical toxicology studies. An adaptive dose escalation strategy will be used.
This study will have up to 9 dose cohorts starting at 0.3 µg/kg. Participants in each dose cohort will be dosed sequentially. Each participant will be directly monitored for safety for at least 24 hours after dosing, with a 6-day period of safety observations completed prior to dosing of the next participant in the same dose cohort.
The study will evaluate single ascending doses of IAP086 by intravenous (IV) infusion with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9.If no dose limiting toxicities occur in the 1 participant in cohorts 1-3 or 3 participants in cohorts 4-9, the study proceeds to the next higher dose following Safety Monitoring Committee (SMC) review.
All cohorts can be expanded to include an additional +3 participants if a treatment related DLT is observed to more fully explore safety events, clinical laboratory results, and virological or biomarker data prior to escalating to the next dose cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Open label dose escalation design. Single Ascending Dose. Where the treatment dose is gradually increased in the cohorts
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: IAP086 0.3 mcg/kgEach participant will receive a single IV infusion of 0.3 mcg/kg IAP086 on Day 0. |
| Cohort 2 | Other | Drug: IAP086 1 mcg/kgEach participant will receive a single IV infusion of 1 mcg/kg IAP086 on Day 0. |
| Cohort 3 | Other | Drug: IAP086 3 mcg/kgEach participant will receive a single IV infusion of 3 mcg/kg IAP086 on Day 0. |
| Cohort 4 | Other | Drug: IAP086 6 mcg/kgEach participant will receive a single IV infusion of 6 mcg/kg IAP086 on Day 0. |
| Cohort 5 | Other | Drug: IAP086 10 mcg/kgEach participant will receive a single IV infusion of 10 mcg/kg IAP086 on Day 0. |
| Cohort 6 | Other | Drug: IAP086 15 mcg/kgEach participant will receive a single IV infusion of 15 mcg/kg IAP086 on Day 0. |
| Cohort 7 | Other | Drug: IAP086 25 mcg/kgEach participant will receive a single IV infusion of 25 mcg/kg IAP086 on Day 0. |
| Cohort 8 | Other | Drug: IAP086 32 mcg/kgEach participant will receive a single IV infusion of 32 mcg/kg IAP086 on Day 0. |
| Cohort 9 | Other | Drug: IAP086 40 mcg/kgEach participant will receive a single IV infusion of 40 mcg/kg IAP086 on Day 0. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (60 listed)
- 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
- Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent
Key exclusion criteria (26 listed)
- 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
- Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
- Clinically significant cardiovascular disease within 12 months prior to screening including but not limited to:
- QTc >450 msec at screening NOTE: QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read
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 |
|---|---|---|
| IAP086 0.3 mcg/kgSingle dose 0.3 mcg/kg IAP086 administered IV | Drug | Cohort 1 |
| IAP086 1 mcg/kgSingle dose 1 mcg/kg IAP086 administered IV | Drug | Cohort 2 |
| IAP086 3 mcg/kgSingle dose 3 mcg/kg IAP086 administered IV | Drug | Cohort 3 |
| IAP086 6 mcg/kgSingle dose 6 mcg/kg IAP086 administered IV | Drug | Cohort 4 |
| IAP086 10 mcg/kgSingle dose 10 mcg/kg IAP086 administered IV | Drug | Cohort 5 |
| IAP086 15 mcg/kgSingle dose 15 mcg/kg IAP086 administered IV | Drug | Cohort 6 |
| IAP086 25 mcg/kgSingle dose 25 mcg/kg IAP086 administered IV | Drug | Cohort 7 |
| IAP086 32 mcg/kgSingle dose 32 mcg/kg IAP086 administered IV | Drug | Cohort 8 |
| IAP086 40 mcg/kgSingle dose 40 mcg/kg IAP086 administered IV | Drug | Cohort 9 |
Primary outcome
Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment
Time frame: From first dose of study treatment through Day 28/end of study
Serious adverse events (SAEs) will be collected from treatment initiation through Day 28/end of study. SAEs are defined according to standard regulatory criteria (e.g., events that result in death, are life threatening, require or prolong hospitalization, result in persistent or significant disability/incapacity, or are otherwise medically important). This outcome includes only SAEs assessed by the study team as at least possibly related to study treatment (possibly or definitely related). Abnormal laboratory values or vital signs are included only if they meet SAE criteria. Non serious adverse events are summarized separately.
Number of Grade 3 or Greater (Severe) Adverse Events (AEs) that are at least possibly related to study treatment
Time frame: From first dose of study treatment through Day 28/end of study
This outcome measures the number of Grade 3 or Greater (Severe) Adverse Events (AEs) that will be collected from treatment initiation through Day 28/end of study. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (The Division of AIDS (DAIDS) AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening.
Number of Adverse Events (AEs) that are at least possibly related to study treatment
Time frame: From first dose of study treatment through Day 28/end of study
Adverse events (AEs) will be collected from treatment initiation through Day 28/end of study. AEs are defined according to standard regulatory criteria (e.g., any unfavorable, unintended medical occurrence (sign, symptom or disease) temporally associated with the use of the investigational product, regardless of whether it is considered related to the treatment. This outcome includes only AEs assessed by the study team at least possibly related to study treatment (possibly or definitely related) Non serious adverse events are summarized under overall safety/AE outcome.
Proportion of participants who prematurely discontinue IAP086 study treatment due to Adverse Events (AEs) or Serious Adverse Events (SAEs) that are at least possibly related to study treatment
Time frame: From first dose of study treatment through Day 28/end of study
Safety data will include signs and symptoms, diagnoses, clinically significant laboratory abnormalities, and clinically significant abnormal vital signs that lead to premature discontinuation of study treatment. Relationship to study treatment will be assessed by the study team using the categories not related, possibly related, or definitely related. This outcome measure assesses the proportion of participants who permanently discontinue IAP086 study treatment due to an adverse event (AE) or serious adverse event (SAE) that is assessed as at least possibly related to study treatment. AEs and SAEs include clinical events, laboratory abnormalities, or abnormal vital signs that result in treatment discontinuation. Relationship to study treatment will be assessed by the study team as not related, possibly related, or definitely related.
5 secondary outcomes
Mean Area Under the Concentration-time Curve (AUC)
Time frame: Pre-infusion through 24-hours post-end of infusion
Mean Maximum Concentration (Cmax) of IAP086
Time frame: Pre-infusion through 24-hours post-end of infusion
Mean Time to Maximal Concentration (Tmax) of IAP086
Time frame: Pre-infusion through 24-hours post-end of infusion
Mean Concentration at 24 hours post-IAP086 (C24)
Time frame: Pre-infusion through 24-hours post-end of infusion
Mean Terminal Half-life of IAP086
Time frame: Pre-infusion through 24-hours post-end of infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Cynthia Gay, MD principal investigator
UNC Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IAP086 0.3 mcg/kg, IAP086 1 mcg/kg and IAP086 3 mcg/kg in people with HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 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 60 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Pedersen (9199666713, susan_pedersen@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment (time frame: From first dose of study treatment through Day 28/end of study). The study lists 4 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 17 Aug 2026.