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Antiretroviral Therapy
TLC-ART for HIV/AIDS
Phase 1
Recruiting
Led By Rachel A Bender Ignacio, MD MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 57 days of study follow-up
Awards & highlights
Study Summary
This trial tests a new HIV treatment platform to determine if it can be used with other drugs. Healthy adults without HIV will participate in the 57-day study at UW Positive Research. There will be 12-16 participants.
Who is the study for?
Healthy adults without HIV, BMI 18.5-29.9, non-smokers or haven't smoked for over a year, low risk for HIV and committed to staying that way during the study. Must use effective contraception if at risk of pregnancy. Excludes those with certain allergies, high blood pressure, recent serious infections or drug/alcohol dependence.Check my eligibility
What is being tested?
The trial is testing TLC-ART 101, a long-acting injectable antiretroviral therapy in healthy adults to see if it's safe and can be used as a platform for other drugs treating HIV. It involves dose adjustments based on responses and includes an optional lymph node biopsy.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to the injection site or systemic effects from the medication components (LPV, RTV, TFV). Participants will be closely monitored for any adverse reactions throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 57 days of study follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~57 days of study follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Co-primary pharmacokinetic outcome: Half-life (T 1/2) of TLC-101 drug substance concentrations in plasma
Co-primary pharmacokinetic outcome: Peak TLC-101 drug substance concentrations (Cmax) in plasma
Co-primary pharmacokinetic outcome: Time to maximum TLC-101 concentration (Tmax) of drug substances in plasma
+2 moreSecondary outcome measures
Secondary pharmacokinetic outcome: Comparison of TLC-101 drug substance concentrations in peripheral blood mononuclear cells compared with plasma levels
TLC-101 concentrations in lymphoid tissues
of tenofovir active drug moiety
Trial Design
5Treatment groups
Experimental Treatment
Group I: TLC-ART 101 Initial DosageExperimental Treatment1 Intervention
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.
Group II: TLC-ART 101 Dosage 3BExperimental Treatment1 Intervention
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
Group III: TLC-ART 101 Dosage 3AExperimental Treatment1 Intervention
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
Group IV: TLC-ART 101 Dosage 2BExperimental Treatment1 Intervention
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.
Group V: TLC-ART 101 Dosage 2AExperimental Treatment1 Intervention
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.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,750 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,221 Total Patients Enrolled
Rachel A Bender Ignacio, MD MPHPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis C infection but no detectable virus.I will stay in the hospital for 3 days for the study.I will have a biopsy of a lymph node in my groin area.I have not taken prescription medications or used hormonal implants/devices in the last 30 days.I am on OTC medications that I cannot stop safely.My gender does not affect my eligibility for this trial.I haven't smoked or used tobacco products in over a year.
Research Study Groups:
This trial has the following groups:- Group 1: TLC-ART 101 Dosage 3B
- Group 2: TLC-ART 101 Dosage 2A
- Group 3: TLC-ART 101 Dosage 2B
- Group 4: TLC-ART 101 Dosage 3A
- Group 5: TLC-ART 101 Initial Dosage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this medical experiment open to individuals of legal age?
"Eligibility for this medical study is limited to those aged between 18 and 65. 161 trials are available for minors, while 481 studies focus on seniors over the age of 65."
Answered by AI
What is the participant capacity of this clinical study?
"Affirmative. As indicated on clinicaltrials.gov, this particular research effort is presently recruiting individuals. The trial was initially posted April 1st 2023 and the most recent update occurred 28th of the same month. 16 participants are needed at a single site for enrollment in this study."
Answered by AI
What are the associated risks of Arm 1 Initial Dosage for participants?
"The data available to us at Power suggests the safety of Arm 1 Initial Dosage can be considered as a score of 1 due to it being a Phase 1 trial, which limits what we know about its effectiveness and safety."
Answered by AI
Are there still opportunities to enroll in this experiment?
"Reportedly, this study is still in the recruitment process. Its original posting date was April 1st 2023 and it has just recently been updated on April 28th of the same year."
Answered by AI
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