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 aged 12 years or older who weigh at least 35 kg (about 77 pounds) at the time of signing up
• People with a confirmed HIV-1 diagnosis, documented through standard approved HIV testing
• People whose blood tests at screening show an HIV viral load (the amount of HIV in the blood) between 1,000 and 100,000 copies per millilitre
• People whose current oral HIV medication has not been working well enough in the 18 months before joining, based on at least one of the following: the viral load has not dropped enough or has stayed detectable after at least 3 months on treatment; there has been a gap of at least 30 consecutive days without taking oral HIV medication; or a change in treatment is needed due to safety concerns, side effects, or interactions with other medications
• People who are currently taking an oral HIV medication regimen and are willing to continue taking it until approximately one week after the Month 6 study visit
• People who can become pregnant must have a negative pregnancy test at both the screening visit and Day 1 of the study
• Adults aged 18 and over who are able to give their own signed informed consent
• Adolescents aged 12 to under 18 whose parent or legal guardian is able to give signed informed consent on their behalf

Who may not be able to join:

• People known to have a specific HIV-1 strain called Subtype A6
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• People with unstable liver disease, cirrhosis, or certain bile duct problems (except for specific mild conditions such as Gilbert's syndrome or gallstones without symptoms)
• People who have both HIV and Hepatitis B virus (HBV) infection, where appropriate Hepatitis B treatment would not be available to them during the study
• People with a history of liver cirrhosis, with or without a viral co-infection
• People with severe liver impairment (classified as Child-Pugh Class C)
• People who also have Hepatitis C virus (HCV) and are currently receiving Hepatitis C treatment at the start of the study
• People the investigator considers to be at high risk of seizures, including those with a poorly controlled seizure disorder
• People with a known allergy or sensitivity to any of the study medications or similar types of drugs
• People the investigator considers to be at significant risk of suicide, taking into account any history of suicidal thoughts or behaviour
• People with a pre-existing physical or mental health condition that, in the investigator's opinion, could affect their ability to safely participate or follow the study schedule
• People who have previously used the medication cabotegravir (CAB)
• People who currently need or are expected to need long-term blood-thinning (anticoagulant) medication
• People currently taking medications known to cause a specific heart rhythm problem called Torsades de Pointes
• People who have received an HIV immunotherapy vaccine within 90 days before screening
• People who have received radiation therapy, certain chemotherapy, most tuberculosis treatments, most blood-thinning medications, or immune-system-altering medications (such as high-dose steroids, interleukins, or interferons) within 28 days before screening
• People who have taken an experimental drug or received an experimental vaccine within a specified timeframe before the first study dose (confirm with trial site for exact timeframe)
• People who are currently taking a medication that is not permitted under the study rules and are unwilling or unable to switch to a different medication
• People who are currently participating in, or expect to be selected for, another interventional clinical study
• People whose drug resistance testing shows that the HIV virus has developed resistance to certain classes of HIV medications (INSTIs or NNRTIs)
• People with certain significant abnormal lab results at screening that the investigator believes would make participation unsafe
• People with a confirmed very high-grade (Grade 4) abnormality in lab results, except for certain cholesterol or lipid abnormalities
• People with certain liver enzyme or bilirubin levels above specified thresholds in blood tests (confirm specific values with trial site)
• People with significantly reduced kidney function, based on specific calculations for adults and adolescents (confirm thresholds with trial site)
• People with a haemoglobin level below 9.0 g/dL (a measure indicating low red blood cells)
• People with a prolonged heart electrical interval (QTc) beyond specified limits on an electrocardiogram (ECG) (confirm with trial site)
• People who are unwilling to receive injections, or for whom injections into the buttock area are not possible
• People with implants or prostheses in the buttock area, or tattoos or skin conditions over the buttock area that could make it difficult to assess injection site reactions
• People with evidence of alcohol or substance use disorder within the previous 12 months that could affect their safety in the study
• Adolescents who are wards of the state or government

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