Phase 2 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 willing and able to sign a consent form and follow the study rules throughout the trial
• People who are 18 years of age or older at the time of signing the consent form, of any gender
• People who have been diagnosed with HIV infection and have a viral load of 500 copies/mL or higher at the screening visit
• People who have never taken any HIV antiretroviral treatment (ART) since their diagnosis, and who agree not to start any ART between signing the consent form and being assigned to a study group

Who may not be able to join:

• People the study doctor believes are unlikely to follow the treatment plan or study requirements, or whose health interests may not be best served by joining
• People who are pregnant, breastfeeding, or have a positive pregnancy blood test at screening; or people who could become pregnant, or male participants who are planning to father a child or donate eggs or sperm, and who are unwilling or unable to use effective contraception from one month before screening until three months after the last dose of the study drug
• People the study doctor believes are in the early acute stage of HIV-1 infection, or who have had serious HIV-related infections or other significant AIDS-defining illnesses within the three months before screening
• People with serious ongoing health conditions that are not well controlled, such as very high blood pressure, advanced heart failure, severe lung disease, or severe liver disease (confirm with trial site for specific thresholds)
• People with significantly abnormal blood test results at screening, including low haemoglobin, elevated liver enzymes, or poor kidney function (confirm with trial site for specific thresholds)
• People who test positive for active hepatitis B with a high viral load, or who test positive for hepatitis C with detectable virus, or who the study doctor believes need treatment for syphilis (those who have already completed a full course of syphilis treatment of at least seven days may still be considered)
• People who used HIV pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the month before screening, or who have previously used long-acting PrEP medications such as cabotegravir or lenacapavir
• People who have used certain immune-suppressing or cell-killing medications in the 30 days before screening, during screening, or who plan to use them during the trial and are unable or unwilling to stop
• People with a known allergy to the study drug, similar drugs, or their ingredients; or people with a history of allergic conditions that required medication to control, such as asthma, hives, or eczema
• People who have had major gastrointestinal surgery before screening (except for straightforward appendix or gallbladder removal), or who the study doctor expects may need major planned surgery during the trial
• People with a history of cancer in the five years before screening, with some exceptions for certain treated skin cancers or cervical carcinoma in situ (confirm with trial site)
• People with a history of alcohol, drug, or substance misuse in the five years before screening that caused social, psychological, or physical harm
• People who cannot tolerate blood draws, have a fear of needles or blood, have donated blood or lost a significant amount of blood (400 mL or more) or received a blood transfusion in the three months before screening, or who plan to donate blood during the trial
• People who have taken part in another clinical trial involving a drug, vaccine, or medical device within the three months before screening

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