Phase 3 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 have recently completed, or are currently taking part in, one of two specific earlier studies (HPTN 083 open label extension or HPTN 084 open label extension, including its pregnancy sub-study) and were receiving the long-acting cabotegravir (CAB LA) injection in that study. Note: people who finished those studies 3 or more months ago must be reviewed by the trial's Medical Monitor before joining, and people who left those studies early are not eligible.
• People who continued to test HIV-negative and were still considered at risk of HIV while taking part in the earlier study, showing they were still benefiting from the treatment.
• People who test HIV-negative at both the screening visit and Day 1 of this trial, using multiple approved HIV tests (all results must be negative/non-reactive). Even one reactive result — even if later found to be a false positive — means a person cannot join.
• Both males and females are eligible, including transgender and cisgender individuals. All sexually active participants would receive counselling on safer sex practices and HIV/STI risk.
• Pregnant participants from the HPTN 084 study may be eligible to join if all other criteria are met.
• People (or their caregivers or legal guardians, where applicable) who are able and willing to sign an informed consent form and follow all study requirements.

Who may not be able to join:

• People who are currently enrolled in the HPTN 083 or HPTN 084 studies but are on the TDF/FTC (oral tablet) arm rather than the CAB LA injection arm. (People on short-term oral TDF/FTC as a bridge may be considered after consultation with the Medical Monitor.)
• People who were removed early from the study medication in the earlier parent study.
• People whose screening blood test shows liver enzyme (ALT) levels that are too high — specifically, more than 5 times the upper limit of normal, or more than 3 times the upper limit of normal combined with elevated bilirubin levels above a certain threshold.
• People with a known active hepatitis B infection, based on specific blood markers. People who have had hepatitis B in the past but have developed immunity to it are not excluded.
• People with unstable liver disease, including conditions such as fluid build-up in the abdomen, brain problems related to liver failure, bleeding problems, low blood protein, swollen veins in the oesophagus or stomach, ongoing jaundice, or cirrhosis. Certain stable or minor liver conditions may not be excluded (confirm with trial site).
• People with a known history of cirrhosis (scarring of the liver), with or without hepatitis.
• People who are currently in, or have recently been in (within the past 30 days), another research study involving an unapproved drug or device — unless the Medical Monitor gives permission.
• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People with skin conditions at the injection site (the buttocks) that could make injections unsafe, at the investigator's discretion. Minor skin conditions may not necessarily be excluded.
• People with implants, tattoos, or other skin conditions over the buttock area that the investigator believes could interfere with giving the injection or assessing the injection site.
• People with blood clotting problems (whether existing or caused by medication) that would make muscle injections unsafe.
• People who are taking a medication that is not allowed under the study rules and are unable or unwilling to switch to a different medication.
• People who are expected to need hepatitis C treatment using interferon or other drugs that could interact badly with the study drug during the trial.
• People who are unlikely to follow the study schedule, keep their appointments, or who plan to move away during the study.
• People with any condition — including substance use disorders — that the investigator believes would put them at unacceptable risk or prevent them from meeting the study requirements.
• People who, in the 14 days before screening, had signs or symptoms that the investigator believes could suggest a new HIV infection — unless HIV has been clearly ruled out through appropriate testing.
• People who are a ward of the state (for example, a child in state care).

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