First in Human Study of TLC-ART 101 (ACTU 2001)

Exclusion Criteria

• •Note the following criteria refer to values from the screening visit
• •Positive HIV-1 fourth generation antigen/antibody test
• •Positive hepatitis B surface antigen test
• •Active HCV infection Note: Participants that are positive for HCV antibody must have a negative HCV RNA
• •Any chronic medical condition deemed significant by the investigator (e.g., asthma, severe allergies, hypertension, heart disease, diabetes mellitus, hyperlipidemia)
• •Taking any chronic oral or systemic prescription medications (including indwelling hormonal implants or hormone-releasing intrauterine devices) within 30 days before the Entry visit
• •Taking any chronic oral or systemic non-prescription (over the counter, OTC) medications that cannot be safely stopped
• •Any clinically significant abnormal value of CBC, creatinine, AST, ALT, alkaline phosphatase, total bilirubin
• •PT/INR, PTT above the upper limit of normal
• •U/A with any clinically significant abnormality
• •Any clinically significant finding on ECG per physician review
• •Urine toxicology screen positive for any illicit drug (other than cannabis if the participant agrees to stop use of cannabis for 14 days prior to entering the study and for the duration of the study, and is believed to be credible in this promise in the opinion of the investigator)
• •BP \> 140 systolic or \> 90 diastolic mmHg
• •Known allergy/sensitivity or any hypersensitivity to LPV, RTV, TFV or either of the lipids in TLC-ART 101 (including anaphylaxis to a COVID-19 mRNA vaccine)
• •Active drug or alcohol use or dependence or psychiatric illness that, in the opinion of the site investigator, would interfere with adherence to study requirements
• •Acute or serious illness requiring systemic treatment, antibiotics, and/or hospitalization within 90 days prior to study entry
• •Scars or tattoos on the central abdomen that would interfere with administration of a subcutaneous injection or assessment of the location where the study medication is planned to be administered (within 1 inch of the umbilicus)
• •Diagnosis of syphilis, gonorrhea or chlamydia in the past year
• •People who are pregnant, intend to become pregnant, or are breastfeeding
• •Allergy to lidocaine or any related "-caine" drug
• •Chronic scars or tattoos in both inguinal areas that might interfere with performance of a lymph node biopsy or increase the likelihood of a poor cosmetic result
• •Anxiety or any other condition that has a high likelihood of interfering with the successful performance of a lymph node biopsy done under local anesthesia
• •Any coagulopathy or condition that would increase the potential for bleeding