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 at least 18 years old (or older if local rules require it) at the time of signing the consent form.
• People whose CD4+ T-cell count (a measure of immune system health) is above 200 cells per microlitre at screening.
• People who have a confirmed HIV-1 diagnosis and a measurable level of HIV-1 in their blood (at least 1,000 copies per millilitre) at screening.
• People who have never taken any HIV antiretroviral (ARV) medications — either alone or in combination — since being diagnosed with HIV-1.
• People who meet minimum body weight requirements: at least 50 kg (110 lbs) for those assigned male at birth, or at least 45 kg (99 lbs) for those assigned female at birth, and a BMI between 18.5 and 35.5.
• People assigned male at birth have no contraceptive requirements for this trial.
• People assigned female at birth who are not pregnant or breastfeeding, and who either cannot become pregnant, or who are using a highly effective contraceptive method (with a failure rate below 1%) during the study and for at least one week after the last dose of the study medication.
• People assigned female at birth who are of childbearing potential must have a negative pregnancy test at screening and on the first day of treatment.
• People who are able to understand and sign an informed consent form. People placed in an institution by a court or public authority are not eligible.

Who may not be able to join:

• People who are currently breastfeeding or plan to breastfeed during the study.
• People who appear to have a very recent (acute) HIV infection, including recent symptoms like fever or fatigue, or signs of very recent HIV exposure within the past 3 months.
• People who have active, serious HIV-related illness classified as CDC Stage 3 disease (a measure of advanced HIV illness), except for a specific type of skin condition called cutaneous Kaposi's sarcoma that does not require systemic treatment.
• People with unstable liver disease or known bile duct problems (though Gilbert's syndrome or asymptomatic gallstones may not be disqualifying — confirm with trial site).
• People with a history of liver cirrhosis, with or without hepatitis co-infection.
• People who also have hepatitis C virus (HCV) infection.
• People who also have hepatitis B virus (HBV) infection alongside HIV.
• People with an uncontrolled cancer diagnosis (those with controlled cancer may be considered on a case-by-case basis).
• People with a pre-existing physical or mental health condition, or issues with alcohol or drug use, that in the trial doctor's opinion could affect their ability to safely participate or follow the study schedule.
• People with a condition that may affect how the body absorbs or processes the study medications, or who cannot swallow oral medication (confirm with trial site).
• People with significant heart disease, including heart failure, irregular heartbeat, angina, coronary artery disease, or a history of heart bypass surgery or coronary procedures.
• People who are taking medications that are not permitted by the trial protocol and who are unable or unwilling to switch to an alternative.
• People with a known allergy or sensitivity to any of the study medications or similar drugs.
• People who need ongoing blood-thinning (anticoagulant) medication, except for low-dose aspirin (325 mg or less) or those with inherited clotting conditions such as haemophilia or Von Willebrand Disease.
• People who have received radiation therapy, chemotherapy, or systemic immune-suppressing treatment within the 60 days before screening.
• People who have used immune-modifying drugs (such as systemic steroids or interferons) or any drug with known anti-HIV activity within 30 days before the first day of treatment.
• People who received an HIV immunotherapy vaccine within 90 days before screening.
• People who received any approved vaccine within 14 days before the first day of treatment.
• People who are currently enrolled in, or who participated in another clinical research study involving an investigational treatment within the past 30 days.
• People whose virus shows resistance to the classes of HIV medications being studied (INSTIs or NRTIs), based on resistance testing done at screening or within the 3 months before screening.
• People whose kidney function is below a certain level, as measured by a specific blood test (eGFR below 60 mL/min/1.73 m²).
• People whose liver enzyme levels (ALT) are more than 3 times the upper limit of normal at screening.
• People with certain severe (Grade 4) abnormal lab results at screening, unless the trial doctor can provide an explanation and the trial medical monitor agrees (confirm with trial site).
• People with any significant abnormal lab result at screening that the trial doctor believes would make participation unsafe.
• People whose heart electrical activity test (ECG) shows a QT interval that is too long: above 450 milliseconds for those assigned male at birth, above 470 milliseconds for those assigned female at birth, or above 480 milliseconds for people with a specific heart conduction condition called bundle branch block.

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