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 18 years of age or older.
• People who have been diagnosed with HIV-1 using FDA-approved tests following CDC testing guidelines.
• People who receive their regular HIV medical care at a location outside of the NIH (National Institutes of Health).
• People who are able to give informed consent to participate.
• People who are willing to allow their biological samples (such as blood) to be stored for future research.
• People who are willing to undergo genetic testing as part of the study.
• People who are currently taking a combination HIV treatment (antiretroviral therapy) according to recognised treatment guidelines.
• People whose HIV virus levels in the blood have been below 40 copies/mL for at least 3 years (small, brief spikes below 200 copies/mL are allowed, as long as levels returned below 40 copies/mL on the next test).
• People whose CD4 immune cell count is at or above 350 cells per microlitre of blood.
• People who are willing to pause their HIV treatment for up to 90 days as part of the study.
• People who are willing to use barrier contraception (such as condoms or dental dams) during sexual activity, or remain abstinent, during the treatment pause and until their HIV viral levels are suppressed again after restarting treatment.

Who may not be able to join:

• People who currently have an active illness or infection, including a fever above 38 degrees Celsius.
• People who are known to have started HIV treatment within the first year of being infected with HIV.
• People who are currently pregnant.
• People who are currently breastfeeding.
• People who are currently taking certain medications that investigators believe may interfere with a specific scan used in the study, including prednisolone, valproate, carbamazepine, phenytoin, phenobarbital, or catecholamines.
• People who are on a type of HIV treatment that is not suitable for a planned treatment pause.
• People who have had a PET/CT scan within the past 6 months.
• People with a history of poorly controlled diabetes that, in the investigators' judgement, would prevent them from completing the PET/CT scan used in the study.
• People who have received a vaccination within the past 4 weeks.
• People who have had a planned HIV treatment pause (known as an ATI) within the past year.
• People who have another health condition for which, in the investigators' judgement, pausing HIV treatment would carry elevated risk.
• People who currently have an active opportunistic infection (a serious infection that occurs due to a weakened immune system), as defined by HIV treatment guidelines.
• People with significant active substance use or a psychiatric condition that, in the investigator's judgement, may affect their ability to attend study visits or complete study procedures.
• People who are allergic to any of the planned anaesthetic medicines expected to be used in the study — specifically lidocaine (local anaesthetic), or midazolam and fentanyl (used for sedation).
• People who are currently taking ongoing oral or injected steroid medications (note: steroid nasal sprays, inhalers, skin creams, and hormone replacement therapy are acceptable).
• People who have a medical reason preventing them from receiving intravenous (IV) contrast dye used in imaging scans.
• People who have a history of developing keloid scars (a type of raised, overgrown scar tissue).
• People with significant kidney problems, including HIV-related kidney disease or a kidney function measurement (eGFR) below 60 mL/min/1.73m² (confirm with trial site for details if taking certain HIV medications).
• People with active or long-term hepatitis B infection, shown by detectable hepatitis B markers in their blood.
• People with active hepatitis C infection, shown by detectable hepatitis C virus in their blood.
• People with a history of HIV-related dementia or a brain condition called progressive multifocal leukoencephalopathy.
• People whose HIV has documented resistance to antiretroviral drugs in a way that, in the investigators' judgement, could risk treatment failure if further resistance developed during the study.
• People with a history of a heart or cardiovascular event, or who are assessed as being at high risk of one (for example, a cardiovascular disease risk score above 20% on a recognised risk calculator).
• People who have had an AIDS-defining illness (a serious condition linked to advanced HIV) within the past 3 years.
• People with significant liver problems, including liver enzyme levels more than 2.5 times the upper limit of normal, or a documented history of cirrhosis.
• People with any other condition that, in the investigator's judgement, would make participation in this study unsuitable.

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