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Phase 1 Study of IAP086 for HIV-1 Infection

This study is testing a new drug called IAP086 in people with HIV-1 infection who are already on stable antiretroviral therapy (ART). The main goal is to see how safe IAP086 is and how well your body tolerates it when given as a single dose. Researchers will be looking for any side effects, especially serious ones. About 30 participants between 18 and 70 years old, who have HIV-1 that is well-controlled by ART, will be included. The study will start with a very low dose of IAP086 and gradually increase it in different groups of participants, as long as it remains safe. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1, open-label study, meaning you and the researchers will know which dose of IAP086 you receive. It will involve up to 30 participants and will test increasing doses of IAP086.
What's involved
You will continue your regular ART medication. The study requires an overnight stay in a research unit where you will receive a single infusion of IAP086 and be monitored for 24 hours.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for at least 28 days after receiving the study treatment to monitor for any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07596888

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
University of North Carolina, Chapel Hill
~30 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:IAP086 0.3 mcg/kgIAP086 1 mcg/kgIAP086 3 mcg/kgIAP086 6 mcg/kgIAP086 10 mcg/kgIAP086 15 mcg/kg

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatment
Measured over From first dose of study treatment through Day 28/end of study
+3 more outcomes measured

Conditions

HIV-1-infection

Explore related trials

HIV InfectionCD4 Gene

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

  • Cynthia Gay, MD · PRINCIPAL_INVESTIGATOR · UNC Chapel Hill

Who to contact

Susan Pedersen
[email protected]
9199666713
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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 17. Participants not of reproductive potential are eligible without requiring the use of contraceptives. Acceptable documentation are specified below.

What this trial measures

  • Number of Serious Adverse Events (SAEs) that are at least possibly related to study treatmentFrom 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 treatmentFrom 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 treatmentFrom 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 treatmentFrom 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.