Phase 1 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 who are willing and able to sign a consent form agreeing to take part in the study.
• People who were born male or female; women must either be unable to become pregnant or have gone through menopause (confirmed by a blood test at the screening visit).
• People aged 18 to 55 years old at the time of the screening visit.
• People whose body weight falls within a healthy range for their height (BMI between 18.0 and 32.0 kg/m²) at the time of screening.
• Women who are not able to become pregnant must have clear medical documentation confirming this; women who have gone through menopause must have a specific hormone level confirmed by a blood test at screening.
• Men who have not had a surgical sterilisation procedure and have a female partner who could become pregnant must agree to use a condom during any sexual activity until the end of the follow-up period.
• Male participants must agree not to donate sperm from the day before the study begins until the follow-up visit is completed.
• People who have stopped all prescription medications at least 30 days (and long enough based on how the medication works) before entering the clinic.
• People who have stopped all over-the-counter medicines, vitamins, food supplements, and herbal products at least 14 days before entering the clinic (paracetamol is allowed up until the day of clinic entry).
• People who are able and willing to avoid alcohol for at least 48 hours before screening and clinic entry, through to the last blood sample collected for the study.
• People who are able and willing to avoid coffee, tea, cola, chocolate, energy drinks, and grapefruit (including juice) for at least 48 hours before entering the clinic.
• People who are in good physical and mental health, as assessed by the study doctor through medical history, physical examination, blood tests, heart trace (ECG), and vital signs.

Who may not be able to join:

• People who are employed by ICON, the study sponsor (GSK), or any companies closely involved in running the trial.
• People with a history of significant allergies to medicines or foods.
• People with a history of serious allergic or hypersensitivity reactions to medicines, or known sensitivity to the study drug.
• People who have used tobacco or nicotine products within the 60 days before the first dose of study medication.
• People with a history of alcohol or drug addiction within the past 5 years.
• People who test positive for drugs or alcohol at the screening visit or on the day of clinic entry.
• People who regularly drink more than 24 units of alcohol per week on average.
• People who test positive for hepatitis B, hepatitis C, or HIV at screening.
• People who have taken part in another clinical drug trial too recently — the exact timeframes depend on the type of drug studied and are assessed on a case-by-case basis (confirm with trial site); or people who have participated in four or more drug studies in the past 12 months.
• People who have donated or lost more than 450 mL of blood in the 60 days before the first dose, or large amounts of blood in the 10 months beforehand (thresholds differ for men and women — confirm with trial site).
• People who have had a significant or sudden illness within 14 days before the first dose that could affect safety assessments, in the study doctor's judgement.
• People with a current or ongoing significant psychiatric condition, including depression, anxiety, sleep problems, or thoughts of self-harm, in the study doctor's judgement.
• People whose veins are not suitable for giving infusions or taking blood samples.
• People who have been in a study involving a specific type of radioactive tracer (carbon-14 at or above a set dose level) within the past year before screening.
• People who have an irregular bowel pattern.
• People with a pre-existing, clinically significant digestive condition, such as irritable bowel syndrome or inflammatory bowel disease, or notable ongoing digestive symptoms.
• People with a medical history or condition that could meaningfully affect how the study drug is absorbed or processed by the body, pose a safety risk, interfere with study results, or prevent them from following the study requirements, in the study doctor's judgement.

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