Could a single shot replace daily HIV pills?
NCT ID NCT05850728
First seen Aug 21, 2026 ยท Last updated Aug 21, 2026
Summary
This early trial tests a new long-acting injectable combination of three antiretroviral drugs in healthy adults without HIV. The goal is to see how the body absorbs and clears the medication and whether it is safe. If the approach works, it could lead to a platform for long-acting HIV prevention and treatment, potentially offering an alternative to daily pills.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLC-ART 101, a combination nanoparticle suspension containing lopinavir, ritonavir, and tenofovir
- What this could lead to
- If successful, this could lead to a long-acting injectable platform for HIV prevention and treatment, reducing the burden of daily pills.
- What could go wrong
- This is an early, small first-in-human study focused on safety and drug levels, not effectiveness. The formulation may not perform as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Apr 2023
- Finished
-
Jun 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: * 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. 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UW Positve Research, Harborview Medical Center
Seattle, Washington, 98104, United States
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