Is NCT07596888 recruiting in Durham, NC?

Yes, NCT07596888 is currently recruiting participants at its Durham, NC location. This hiv-1-infection clinical trial is actively enrolling qualified participants.

How do I join the hiv-1-infection clinical trial in Durham?

To join this clinical trial in Durham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Durham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV-1-infection Clinical Trial in Durham, NC

About This HIV-1-infection Study in Durham

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.

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

Inclusion Criteria

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. 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

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

Exclusion Criteria

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:

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT07596888) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV-1-infection Treatment Options in Durham, NC

If you're searching for hiv-1-infection treatment options in Durham, NC, this clinical trial (NCT07596888) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced hiv-1-infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv-1-infection clinical trials near you to find additional studies recruiting in your area.

HIV-1-infection Clinical Trial in Durham, NC

Expert Care in Durham

IRB Approved

No-Cost Care

Apply for This Durham Location

Why Participate?

Simple Process