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:

• Adults aged between 18 and 65 years (inclusive) whose immune system has not fully recovered despite HIV treatment (known as incomplete immune reconstitution).
• People who have been on antiretroviral therapy (HIV medication) for more than 4 years, with the virus being undetectable in the blood (fewer than 50 copies/mL) for more than 3 years, while their CD4 cell count (a measure of immune system strength) has stayed persistently below 350 cells/μL.
• People whose CD4 cell count, measured within the past year, has remained below 350 cells/μL but above 200 cells/μL.
• People who have been taking a dolutegravir-based HIV treatment regimen for at least 1 year, with no detected drug resistance, no core regimen changes in the past year, and who are willing to continue that regimen for at least 1 year after joining the trial.
• People who are willing and able to give written consent before any study procedures begin, and to follow all study requirements.

Who may not be able to join:

• People who also have hepatitis B, C, D, or E, or who have high levels of certain other viruses (CMV or EBV above 1000 copies/mL) in their blood.
• People who have HIV-2 alone, or who have both HIV-1 and HIV-2 at the same time.
• People who have used certain HIV medications called efavirenz or rilpivirine within the past 2 years.
• People who have a history of resistance to a class of HIV medications called NNRTIs.
• People who show signs of other serious illnesses.
• People who regularly use corticosteroids or other medications that suppress the immune system.
• People who have serious HIV-related or non-HIV-related health complications.
• People who have serious underlying conditions in other body systems unrelated to HIV.
• People who have serious uncontrolled conditions affecting the kidneys, heart, lungs, nervous system, mental health, digestive system, hormonal system, or immune system, or who have cancer.
• People who have received immune-suppressing or systemic cytotoxic (cell-destroying) therapies within the past 6 months (confirm with trial site).
• People with evidence of substance misuse in the past 6 months, or a positive drug test.
• People currently participating in another clinical trial that could interfere with this one.
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People who are unable or unwilling to give informed consent or follow study requirements.
• People with any other serious condition that could interfere with how the trial is conducted.

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