Human Immunodeficiency VirusPhase 1NCT05850728
First in Human Study of TLC-ART 101 (ACTU 2001)
A Phase 1 study testing TLC-ART in people with Human Immunodeficiency Virus and Treatment, run by University of Washington at 1 site in United States.
Trial summary
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Treatment, Antiretroviral Therapy
- What is being tested?
- TLC-ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 28 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy with a BMI between 18.5 to 29.9 kg/m2 (Amended through 31.9kg/m2)
- Non-smoker or former smoker (defined as no smoking or no vaping or no use of tobacco cessation products for greater than 1 year)
- Persons of any gender are eligible if they otherwise meet all other entry criteria.
- Assessed by the study staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure until after completing the study.
- Willing and able to give informed consent.
- If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential must agree to use specific forms of contraception throughout the study. At least two of the following must be used throughout the study:
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- Condom (male or female)
- Diaphragm or cervical cap
- Copper-based intrauterine device
- Vasectomy in the male partner
- Note: Select participants will have a 72-hour in-patient stay at UW Medical Center.
- Note: Select participants will undergo an inguinal lymph node biopsy.
Who cannot join
- 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
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- 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
- Additional Exclusion Criteria for Participants who will Undergo Lymph Node Biopsy
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Positve Research, Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: First in Human Clinical Trial of a Next Generation, Long-acting Injectable, Combination Antiretroviral Therapy Platform
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.
Read the detailed description
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study has two primary aims as follows:
- To characterize the plasma concentration-time course and pharmacokinetics (PK) of a single dose of the drug substances of TLC-ART 101 (lopinavir, ritonavir, and tenofovir) administered by subcutaneous injection within the drug combination nanoparticle.
- To characterize the safety and tolerability of a single subcutaneous injection of TLC-ART 101.
There are 4 exploratory mechanistic objectives (with related endpoints) as follows:
- To characterize the pharmacokinetics of the drug substances in human peripheral blood mononuclear cells (PBMCs)
- To characterize the concentrations of intracellular TFV-diphosphate (the active moiety of TFV) in PBMCs
- To explore whether the pharmacokinetic parameters of the 3 drug substances differ by sex following a single dose NB: This analysis not performed due to truncation of study to 3 cohorts and low ratio of female to male sex participants
- To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101.
- Being tested
- TLC-ART
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC-ARTDrug
TLC-ART 101 contains lopinavir, ritonavir, and tenofovir in a combination nanoparticle suspension
| Study group | Role | What they receive |
|---|---|---|
| TLC-ART 101 Initial Dosage | Experimental | The arms will all receive the nanoparticle suspension of lopinavir, ritonavir, and tenofovir (TLC-ART 101). The arms are also called cohorts. The dose a participant receives will vary, depending upon the study results and the time of when they enroll in the study.
The initial dosage administered to 4 participants will contain:
lopinavir 15.6 mg, ritonavir 4.2 mg, and tenofovir 9.15 mg in 1.5mL of the formulation
If the initial dose is appropriate, an additional 8 participants will be enrolled in Arm 1, for a total study size of 12 participants. Receives: Drug: TLC-ART |
| TLC-ART 101 Dosage 2A | Experimental | In the scenario in which the dosage in Arm 1 produces insufficient pharmacokinetics (PK), the dosage will be increased 2 fold in Arm 2A and administered to 4 participants.
If Arm 2A shows ideal PK parameters, and additional 8 participants will be enrolled in this arm, for a total study size of 16 participants. Receives: Drug: TLC-ART |
| TLC-ART 101 Dosage 2B | Experimental | In the scenario in which the dosage in Arm 1 produces excessive drug levels, the dosage will be decreased by up to 2-5 fold (2-5x descending dose) and administered to 4 participants.
If Arm 2B shows ideal PK parameters, and additional 8 participants will be enrolled in this arm, for a total study size of 16 participants. Receives: Drug: TLC-ART |
| TLC-ART 101 Dosage 3A | Experimental | In the scenario in which the dosage in Arm 2A produces insufficient drug levels, the dosage may be further increased by 2-fold from Arm 2A dosage (4x total dosage increase) and administered to an additional 4 participants.
If Arm 3A shows ideal PK parameters, and additional 4 participants will be enrolled in this arm, for a total study size of 16 participants Receives: Drug: TLC-ART |
| TLC-ART 101 Dosage 3B | Experimental | In the scenario in which the dosage in Arm 2B produces excessive drug levels, the dosage may be further decreased further by up to 2-5-fold from Arm 2B dosage (4-10x dose decrease) and administered to 4 participants.
If Arm 3B shows ideal PK parameters, and additional 4 participants will be enrolled in this arm, for a total study size of 16 participants Receives: Drug: TLC-ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary Pharmacokinetic Outcome: Peak TLC-101 Drug Substance Concentrations (Cmax) in Plasma
The maximum drug substance plasma concentrations of lopinavir, ritonavir, and tenofovir obtained following a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Measured: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Co-primary Pharmacokinetic Outcome: Time to Maximum TLC-101 Concentration (Tmax) of Drug Substances in Plasma
Time (hours) to reach the maximum concentrations of lopinavir, ritonavir, and tenofovir after a single administration of TLC-ART-101. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Measured: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Co-primary Pharmacokinetic Outcome: Total TLC-101 Drug Substance Exposure (Area Under the Curve or AUC) in Plasma
Area under the curve of plasma concentrations of lopinavir, ritonavir, and tenofovir over the study timecourse after a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Measured: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Co-primary Pharmacokinetic Outcome: Estimated Half-life (T 1/2) of TLC-101 Drug Substance Concentrations in Plasma
The apparent terminal half-life of drug substance plasma concentrations of lopinavir, ritonavir, and tenofovir after a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days. The apparent terminal half-life T1/2,z was computed by regression on at least 3 detectable points if Tlast was at 57 or 64 days (end of study) or 2 detected and the first undetectable if Tlast < 57 or 64 days; detectable timepoints following undetectable plasma levels were excluded from the T1/2 estimation.
Measured: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Primary Safety Outcome
Treatment emergent adverse events related to TLC-ART 101 as graded by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017). Only related injection site reactions (ISRs) or other related systemic events are reported here. Comprehensive adverse events, related and unrelated, are reported in the Adverse Event section.
Measured: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Apr 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Pharmacologically-guided adaptive design, in which the dose is increased or decreased if needed, based on results from prior participant arms
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Bender Ignacio, University of Washington
- Investigators
- Rachel A Bender Ignacio, MD MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850728
- Sponsor's protocol ID
- STUDY00007490
- Other IDs
- U01AI148055
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2023
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once study is completed, reasonable request for de-identified datasets may be considered by the study PI and sponsor
Publications
Freeling JP, Koehn J, Shu C, Sun J, Ho RJ. Anti-HIV drug-combination nanoparticles enhance plasma drug exposure duration as well as triple-drug combination levels in cells within lymph nodes and blood in primates. AIDS Res Hum Retroviruses. 2015 Jan;31(1):107-14. doi: 10.1089/aid.2014.0210.
PubMed 25402233McConnachie LA, Kinman LM, Koehn J, Kraft JC, Lane S, Lee W, Collier AC, Ho RJY. Long-Acting Profile of 4 Drugs in 1 Anti-HIV Nanosuspension in Nonhuman Primates for 5 Weeks After a Single Subcutaneous Injection. J Pharm Sci. 2018 Jul;107(7):1787-1790. doi: 10.1016/j.xphs.2018.03.005. Epub 2018 Mar 13.
PubMed 29548975Kraft JC, McConnachie LA, Koehn J, Kinman L, Collins C, Shen DD, Collier AC, Ho RJ. Long-acting combination anti-HIV drug suspension enhances and sustains higher drug levels in lymph node cells than in blood cells and plasma. AIDS. 2017 Mar 27;31(6):765-770. doi: 10.1097/QAD.0000000000001405.
PubMed 28099191Kraft JC, Treuting PM, Ho RJY. Indocyanine green nanoparticles undergo selective lymphatic uptake, distribution and retention and enable detailed mapping of lymph vessels, nodes and abnormalities. J Drug Target. 2018 Jun-Jul;26(5-6):494-504. doi: 10.1080/1061186X.2018.1433681. Epub 2018 Feb 12.
PubMed 29388438Perazzolo S, Shireman LM, McConnachie LA, Koehn J, Kinman L, Lee W, Lane S, Collier AC, Shen DD, Ho RJY. Integration of Computational and Experimental Approaches to Elucidate Mechanisms of First-Pass Lymphatic Drug Sequestration and Long-Acting Pharmacokinetics of the Injectable Triple-HIV Drug Combination TLC-ART 101. J Pharm Sci. 2020 May;109(5):1789-1801. doi: 10.1016/j.xphs.2020.01.016. Epub 2020 Jan 29.
PubMed 32006525Perazzolo S, Shireman LM, Shen DD, Ho RJY. Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 1: Model for the Free-Drug Mixture. J Pharm Sci. 2022 Feb;111(2):529-541. doi: 10.1016/j.xphs.2021.10.007. Epub 2021 Oct 19.
PubMed 34673093Perazzolo S, Shen DD, Ho RJY. Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 2: Model for the Drug-combination Nanoparticles. J Pharm Sci. 2022 Mar;111(3):825-837. doi: 10.1016/j.xphs.2021.10.009. Epub 2021 Oct 19.
PubMed 34673094
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Clinical Trial of a Next Generation, Long-acting Injectable, Combination Antiretroviral Therapy Platform
- ClinicalTrials.gov ID
- NCT05850728
- Acronym / sponsor ID
- STUDY00007490
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.
Detailed description
This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study has two primary aims as follows:
- To characterize the plasma concentration-time course and pharmacokinetics (PK) of a single dose of the drug substances of TLC-ART 101 (lopinavir, ritonavir, and tenofovir) administered by subcutaneous injection within the drug combination nanoparticle.
- To characterize the safety and tolerability of a single subcutaneous injection of TLC-ART 101.
There are 4 exploratory mechanistic objectives (with related endpoints) as follows:
- To characterize the pharmacokinetics of the drug substances in human peripheral blood mononuclear cells (PBMCs)
- To characterize the concentrations of intracellular TFV-diphosphate (the active moiety of TFV) in PBMCs
- To explore whether the pharmacokinetic parameters of the 3 drug substances differ by sex following a single dose NB: This analysis not performed due to truncation of study to 3 cohorts and low ratio of female to male sex participants
- To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Pharmacologically-guided adaptive design, in which the dose is increased or decreased if needed, based on results from prior participant arms
| Arm | Type | Receives |
|---|---|---|
| TLC-ART 101 Initial Dosage | Experimental | Drug: TLC-ARTThe arms will all receive the nanoparticle suspension of lopinavir, ritonavir, and tenofovir (TLC-ART 101). The arms are also called cohorts. The dose a participant receives will vary, depending upon the study results and the time of when they enroll in the study. The initial dosage administered to 4 participants will contain: lopinavir 15.6 mg, ritonavir 4.2 mg, and tenofovir 9.15 mg in 1.5mL of the formulation If the initial dose is appropriate, an additional 8 participants will be enrolled in Arm 1, for a total study size of 12 participants. |
| TLC-ART 101 Dosage 2A | Experimental | Drug: TLC-ARTIn the scenario in which the dosage in Arm 1 produces insufficient pharmacokinetics (PK), the dosage will be increased 2 fold in Arm 2A and administered to 4 participants. If Arm 2A shows ideal PK parameters, and additional 8 participants will be enrolled in this arm, for a total study size of 16 participants. |
| TLC-ART 101 Dosage 2B | Experimental | Drug: TLC-ARTIn the scenario in which the dosage in Arm 1 produces excessive drug levels, the dosage will be decreased by up to 2-5 fold (2-5x descending dose) and administered to 4 participants. If Arm 2B shows ideal PK parameters, and additional 8 participants will be enrolled in this arm, for a total study size of 16 participants. |
| TLC-ART 101 Dosage 3A | Experimental | Drug: TLC-ARTIn the scenario in which the dosage in Arm 2A produces insufficient drug levels, the dosage may be further increased by 2-fold from Arm 2A dosage (4x total dosage increase) and administered to an additional 4 participants. If Arm 3A shows ideal PK parameters, and additional 4 participants will be enrolled in this arm, for a total study size of 16 participants |
| TLC-ART 101 Dosage 3B | Experimental | Drug: TLC-ARTIn the scenario in which the dosage in Arm 2B produces excessive drug levels, the dosage may be further decreased further by up to 2-5-fold from Arm 2B dosage (4-10x dose decrease) and administered to 4 participants. If Arm 3B shows ideal PK parameters, and additional 4 participants will be enrolled in this arm, for a total study size of 16 participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy with a BMI between 18.5 to 29.9 kg/m2 (Amended through 31.9kg/m2)
- Non-smoker or former smoker (defined as no smoking or no vaping or no use of tobacco cessation products for greater than 1 year)
- Persons of any gender are eligible if they otherwise meet all other entry criteria.
- Assessed by the study staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure until after completing the study.
- Willing and able to give informed consent.
Key exclusion criteria (24 listed)
- 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)
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 |
|---|---|---|
| TLC-ARTTLC-ART 101 contains lopinavir, ritonavir, and tenofovir in a combination nanoparticle suspension | Drug | TLC-ART 101 Dosage 2A, TLC-ART 101 Dosage 2B, TLC-ART 101 Dosage 3A, TLC-ART 101 Dosage 3B, TLC-ART 101 Initial Dosage |
Primary outcome
Co-primary Pharmacokinetic Outcome: Peak TLC-101 Drug Substance Concentrations (Cmax) in Plasma
Time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
The maximum drug substance plasma concentrations of lopinavir, ritonavir, and tenofovir obtained following a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Co-primary Pharmacokinetic Outcome: Time to Maximum TLC-101 Concentration (Tmax) of Drug Substances in Plasma
Time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Time (hours) to reach the maximum concentrations of lopinavir, ritonavir, and tenofovir after a single administration of TLC-ART-101. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Co-primary Pharmacokinetic Outcome: Total TLC-101 Drug Substance Exposure (Area Under the Curve or AUC) in Plasma
Time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Area under the curve of plasma concentrations of lopinavir, ritonavir, and tenofovir over the study timecourse after a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Co-primary Pharmacokinetic Outcome: Estimated Half-life (T 1/2) of TLC-101 Drug Substance Concentrations in Plasma
Time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
The apparent terminal half-life of drug substance plasma concentrations of lopinavir, ritonavir, and tenofovir after a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days. The apparent terminal half-life T1/2,z was computed by regression on at least 3 detectable points if Tlast was at 57 or 64 days (end of study) or 2 detected and the first undetectable if Tlast < 57 or 64 days; detectable timepoints following undetectable plasma levels were excluded from the T1/2 estimation.
Primary Safety Outcome
Time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)
Treatment emergent adverse events related to TLC-ART 101 as graded by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017). Only related injection site reactions (ISRs) or other related systemic events are reported here. Comprehensive adverse events, related and unrelated, are reported in the Adverse Event section.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25402233Freeling JP, Koehn J, Shu C, Sun J, Ho RJ. Anti-HIV drug-combination nanoparticles enhance plasma drug exposure duration as well as triple-drug combination levels in cells within lymph nodes and blood in primates. AIDS Res Hum Retroviruses. 2015 Jan;31(1):107-14. doi: 10.1089/aid.2014.0210.
- Background: PubMed 29548975McConnachie LA, Kinman LM, Koehn J, Kraft JC, Lane S, Lee W, Collier AC, Ho RJY. Long-Acting Profile of 4 Drugs in 1 Anti-HIV Nanosuspension in Nonhuman Primates for 5 Weeks After a Single Subcutaneous Injection. J Pharm Sci. 2018 Jul;107(7):1787-1790. doi: 10.1016/j.xphs.2018.03.005. Epub 2018 Mar 13.
- Background: PubMed 28099191Kraft JC, McConnachie LA, Koehn J, Kinman L, Collins C, Shen DD, Collier AC, Ho RJ. Long-acting combination anti-HIV drug suspension enhances and sustains higher drug levels in lymph node cells than in blood cells and plasma. AIDS. 2017 Mar 27;31(6):765-770. doi: 10.1097/QAD.0000000000001405.
- Background: PubMed 29388438Kraft JC, Treuting PM, Ho RJY. Indocyanine green nanoparticles undergo selective lymphatic uptake, distribution and retention and enable detailed mapping of lymph vessels, nodes and abnormalities. J Drug Target. 2018 Jun-Jul;26(5-6):494-504. doi: 10.1080/1061186X.2018.1433681. Epub 2018 Feb 12.
- Background: PubMed 32006525Perazzolo S, Shireman LM, McConnachie LA, Koehn J, Kinman L, Lee W, Lane S, Collier AC, Shen DD, Ho RJY. Integration of Computational and Experimental Approaches to Elucidate Mechanisms of First-Pass Lymphatic Drug Sequestration and Long-Acting Pharmacokinetics of the Injectable Triple-HIV Drug Combination TLC-ART 101. J Pharm Sci. 2020 May;109(5):1789-1801. doi: 10.1016/j.xphs.2020.01.016. Epub 2020 Jan 29.
- Background: PubMed 34673093Perazzolo S, Shireman LM, Shen DD, Ho RJY. Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 1: Model for the Free-Drug Mixture. J Pharm Sci. 2022 Feb;111(2):529-541. doi: 10.1016/j.xphs.2021.10.007. Epub 2021 Oct 19.
- Background: PubMed 34673094Perazzolo S, Shen DD, Ho RJY. Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 2: Model for the Drug-combination Nanoparticles. J Pharm Sci. 2022 Mar;111(3):825-837. doi: 10.1016/j.xphs.2021.10.009. Epub 2021 Oct 19.
- TLC ART Program homepageLink provided by the sponsor.
- UW Positive Research websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once study is completed, reasonable request for de-identified datasets may be considered by the study PI and sponsor
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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. This study is not recruiting at the moment.
Rachel A Bender Ignacio, MD MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLC-ART in people with Human Immunodeficiency Virus and Treatment, run by University of Washington at 1 site 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 12 inclusion and 24 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: finished, as of the sponsor's last update on 21 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 1 site 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?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary Pharmacokinetic Outcome: Peak TLC-101 Drug Substance Concentrations (Cmax) in Plasma (time frame: Duration of follow-up in days for this study (57 days in Cohort 1 and 64 days in Cohorts 2A/2B)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850728, which also lists 7 linked publications.
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 21 Aug 2026.