Phase 1 HIV and AIDS Trial, Recruiting

Written by an AI model from 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 aged 18 to 55 years old at the time of signing the consent form
• People who are generally in good health
• People of any gender may be considered for this trial
• People assigned female at birth may be considered if they are not pregnant, not planning to become pregnant, and not breastfeeding during the study — and either cannot become pregnant, or are using a highly effective form of contraception for a specific period after the last dose of the study drug
• People who are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

• People with a history of significant heart, lung, liver, kidney, digestive, hormone, blood, nerve, or mental health conditions that could affect how the body processes medicines or interfere with the study results
• People with abnormal blood pressure readings
• People who have had lymphoma, leukaemia, or most other types of cancer in the past 5 years (certain skin cancers that were fully removed with no spread for at least 3 years may be considered)
• People who have had breast cancer in the past 10 years
• People with a current or long-term history of liver disease, or known problems with the liver or bile ducts
• People who have had a clinically significant liver infection (hepatitis) in the past 6 months
• People with a chronic hepatitis B infection
• People with a known allergy or sensitivity to any of the study medicines or related substances
• People with an existing skin condition that could interfere with checking the injection site after dosing
• People whose muscle mass may be insufficient to safely receive the study injection into a muscle (confirm with trial site)
• People with a history of, or current, high-risk behaviours that may increase the chance of acquiring HIV
• People with a physical or mental health condition that might make it difficult to follow the study schedule or that could affect their safety during the trial
• People who have taken any over-the-counter, prescription, or herbal medicines within 7 days before the first dose
• People who have taken part in trials involving more than 4 new investigational medicines in the 12 months before the first dose
• People who are currently enrolled in, or have recently taken part in, another investigational study
• People who test positive for HIV antibodies or antigens
• People with certain abnormal blood test results, including raised liver enzyme levels, raised bilirubin levels, or reduced kidney function below a set threshold
• People who regularly use tobacco or nicotine products, regularly drink alcohol, or use recreational drugs
• People with a certain type of heart rhythm abnormality detected on an ECG (a specific measurement called QTcF greater than 450 milliseconds)
• People with evidence of a previous heart attack, significant heart rhythm problems, or pauses in heart rhythm lasting more than 3 seconds
• People with a tattoo, skin condition, silicone implant, or filler at or near the injection site that could interfere with assessments or administration of the study drug

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