Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 18 and 55 years of age.
• People who are able to give their informed consent to participate.
• People who are willing to allow their samples and data to be stored and shared for future research.
• People who agree to use a barrier method of contraception (such as condoms) or abstain from sexual activity from the screening stage through to the end of the study.

Who may not be able to join:

• People who currently have HIV or hepatitis A, B, or C.
• People whose Body Mass Index (BMI) is below 18.5 or above 30.0 (confirm with trial site for how this is measured).
• People whose body weight has changed by more than 5% in the past 6 months.
• People who have had or currently have heart disease, such as heart failure, heart block, or a significantly abnormal heart reading on an ECG.
• People who have had or currently have liver disease, or whose liver enzyme levels (ALT) are more than twice the normal upper limit on a blood test.
• People who have had or currently have kidney disease or reduced kidney function, as measured by a specific blood test calculation.
• People who currently have cancer, or who have had cancer within the past 5 years — with an exception for certain localised skin cancers that do not require systemic (whole-body) treatment.
• People who have had bariatric (weight-loss) surgery in the past.
• People who have been diagnosed with diabetes, or whose blood sugar control marker (HbA1c) is above 6.4% on screening blood tests.
• People whose fasting blood sugar level is above 126 mg/dL.
• People who have had or currently have an underactive or overactive thyroid, or an abnormal thyroid hormone level on testing — unless the investigator considers the deviation minor and not clinically significant.
• People who have had or currently have asthma or chronic obstructive pulmonary disease (COPD).
• People who have psychological conditions, such as clinical depression or bipolar disorder, that would make safe participation in the study difficult.
• People who are pregnant or within one year of giving birth.
• People who are currently breastfeeding.
• People whose blood pressure is above 140/90 mmHg, or who are currently taking blood pressure-lowering medication.
• People whose haemoglobin (a measure of red blood cell health) falls outside an acceptable range — more than 10% below the lower limit or more than 10% above the upper limit of normal for the study laboratory (confirm with trial site).
• People who have had a problem with illicit drugs, opioids, or alcohol in the past 5 years, or who are currently using illicit drugs or opioids, or drinking excessively as assessed by a standard questionnaire.
• People who are currently taking any of the following medications or supplements: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's wort, antacids or laxatives containing calcium or other minerals, sucralfate, buffered medications, oral calcium, iron, magnesium or zinc supplements (including multivitamins containing these), dalfampridine, metformin, dofetilide, thyroid medications, corticosteroids, or any weight-loss medications including semaglutide, tirzepatide, or over-the-counter diet pills.
• People who have used the HIV prevention medications TAF, TDF, and/or FTC (as PrEP or in a research study) within the past 6 months.
• People who have ever been exposed to cabotegravir or lenacapavir (for example, as HIV PrEP or as part of a research study).
• People who are currently taking other prescription or non-prescription medications that may interact with the study drugs or affect study results, as determined by the investigators.
• People who have a history of a bad or allergic reaction to the study drugs.
• People whose daily caffeine intake is more than 500 mg (roughly equivalent to about 4 cups of coffee).
• People who currently smoke or use any tobacco products.
• People who have significantly changed their diet or exercise habits in the past 3 months, or who plan to do so during the study, if the investigator believes this would affect the reliability of the results.
• People considered by the investigators to be at high risk from certain sexual activity, or who are unwilling or unable to use barrier contraception during the study.
• People who have any other health condition, medication use, or dietary pattern that, in the investigators' view, would increase risk, prevent them from following study procedures, prevent them from completing the study, or make the results difficult to interpret.

Important: Always verify eligibility with the trial site directly before applying.