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 who are at least 18 years old but have not yet turned 51 on the day they sign the consent form.
• People who are willing to follow the study rules and attend all required follow-up visits for the full duration of the study.
• People who have understood the information about the study and its potential risks, as assessed by the study team, and who provide written consent before any study procedures begin.
• Sexually active women who could become pregnant must agree to use an effective form of contraception starting 21 days before receiving the study product and continuing until 4 months after the last dose — accepted methods include an intrauterine device (IUD), a contraceptive implant, hormonal contraception, or a male partner who has had a confirmed successful vasectomy.
• Women who have had their uterus removed (hysterectomy), both ovaries removed, or tubes tied, or who are postmenopausal (over 45 with no periods for at least 2 years, or any age with no periods for at least 6 months and a specific hormone level confirmed by a blood test) are not required to use contraception.
• People who are willing to not donate blood or any other tissues during the study.

Additional criteria for people living with HIV (PLWH):

• People with a confirmed HIV diagnosis, shown either through medical records or a clinic test at the screening visit.
• People whose CD4 cell count (a measure of immune system health) is 500 cells/µl or above at screening.
• People who have been on a combination HIV treatment regimen (at least 2 medications) continuously for at least 12 months, with their HIV viral load kept below 50 copies/ml for more than 6 months before joining the trial, confirmed on at least 2 separate occasions including the screening test.
• People whose HIV viral load is below 50 copies/ml at the time of screening (tested within 28 days before receiving the study product).
• People who commit to continuing their HIV treatment regimen throughout the entire study.

Additional criterion for people without HIV (PLWoH):

• People without HIV must be considered at low risk of acquiring HIV and must be willing to maintain low-risk behaviours for the full duration of the trial.

Who may not be able to join:

• People who have a significant ongoing or progressive medical condition (other than HIV, for the HIV-positive group) that the investigator considers would make participation unsuitable.
• People living with HIV who have had an AIDS-defining illness in the past, or whose CD4 count has ever dropped below 200 cells/µl.
• Women who are pregnant, breastfeeding, or planning to become pregnant at any point from screening through to the end of the study.
• People who have had issues with alcohol or substance use in the past 6 months that the investigator believes could affect their ability to follow the study requirements.
• People who have been diagnosed by a doctor with a bleeding disorder, such as a clotting factor deficiency or a platelet disorder that requires special precautions (note: people who bruise or bleed easily but have no formal diagnosis and have had injections or blood draws without problems may still be eligible — confirm with trial site).
• People who have had their spleen removed.
• People who have previously received a vaccine that uses an adenovirus as a delivery vehicle (confirm with trial site if unsure).
• People who have received a live or weakened vaccine, or any other vaccine, within the past 60 days, or who plan to receive a vaccine within 180 days after receiving the study product.
• People who have received a blood transfusion or blood-derived products within the past 3 months.
• People who are currently in another clinical trial, have been in one within the past 3 months, or are expected to join one during this study.
• People who have previously received an investigational HIV vaccine, a monoclonal antibody, or a polyclonal immunoglobulin product (note: people who received a placebo in a previous HIV vaccine or antibody trial may still be considered if documentation is available and the Medical Monitor approves).
• People who have had a severe reaction to a vaccine in the past, such as a severe allergic reaction (anaphylaxis), breathing difficulties, or severe swelling.
• People with a psychiatric condition that affects their safety or ability to follow the study requirements — this specifically includes people with a history of psychosis within the past 3 years, an ongoing risk of suicide, or a history of a suicide attempt or gesture within the past 3 years.
• People for whom the Principal Investigator believes participation would not be in their best interest.
• People who have had a seizure within the last 3 years (people with a history of seizures who have not needed seizure medication and have not had a seizure for 3 years may still be eligible — confirm with trial site).
• People with chronic hepatitis B infection, current or recent hepatitis C infection, or active syphilis confirmed by specific blood tests.
• People who have had a cancer diagnosis within the past 5 years or who currently have cancer.
• People who have had a serious active infection (other than HIV, for the HIV-positive group) requiring intravenous antibiotic, antiviral, or antifungal treatment within the 30 days before enrolment.
• People with abnormal laboratory test results at screening, as defined by the study protocol (confirm with trial site).
• People with a history of immune system disorders or autoimmune diseases (other than HIV in the HIV-positive group), or those who have used corticosteroids, immune-suppressing medications, cancer treatments, or other medications considered significant by the investigator within the past 6 months.

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