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 have given written consent to participate.
• People who started combination HIV treatment within 90 days of being diagnosed with acute HIV infection.
• People who have been on HIV treatment for at least 12 months, with no break in treatment longer than 28 days in a row during the 12 months before joining.
• People whose HIV treatment includes a specific type of medication called an integrase inhibitor, combined with two other HIV drugs (or a dolutegravir/lamivudine combination), taken for at least 6 weeks before joining.
• People who are willing to take part in a planned, supervised treatment break (called an Analytic Treatment Interruption) and willing to restart HIV treatment according to the study rules.
• People who are willing to follow the study treatment plan and attend all required study visits.
• People who weigh between 50 kg and 150 kg at the screening stage.
• People whose CD4 cell count (a measure of immune system health) is 450 or above, tested within 60 days before joining.
• People whose HIV viral load has been undetectable for at least one year, with a test confirming this within 60 days before joining.
• People with certain laboratory test results within an acceptable range, taken within 60 days of joining (confirm with trial site for specific values).
• People assigned female at birth who could become pregnant must have a negative pregnancy test within 48 hours before or at the time of joining.
• People who could become pregnant and are sexually active in ways that could lead to pregnancy must agree to use two forms of contraception, one of which must be a highly effective method, and one of which must be a barrier method.
• People who have HLA typing results available (a specific genetic test required before being assigned to a treatment group).
• People who have already completed a procedure to collect immune cells (called leukapheresis or LVBD) before the study entry step.

Who may not be able to join:

• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
• People who have previously received a type of HIV treatment called broadly neutralising antibodies.
• People who have received any non-HIV monoclonal antibody therapy (a type of immune-based medicine) within the past year.
• People who have previously received a treatment designed to "wake up" hidden HIV (called a latency-reversing agent).
• People who have received an HIV vaccine or other experimental vaccine within the past 6 months.
• People who have received a live-virus vaccine within the past 60 days, or any vaccine within the past 14 days.
• People who have received a specific type of vaccine used against COVID-19 (simian adenovirus-vectored, such as AZD1222) within the past 12 months.
• People with a known allergy or sensitivity to any component of the study treatments.
• People with a known severe allergy to chicken eggs.
• People with a known history of a severe reaction or anaphylaxis (a serious allergic reaction) to a previous vaccine or antibody-based medicine.
• People with significant drug allergies or sensitivities, such as anaphylaxis or serious liver reactions.
• People with any history of anaphylaxis or related symptoms such as hives, breathing difficulties, or swelling.
• People with a history of or current bleeding disorders, clotting problems, or platelet disorders, or who take ongoing blood-thinning medication.
• People with a history of inflammatory neurological diseases (conditions involving inflammation of the nervous system).
• People who have been pregnant, experienced a serious head injury, or had major surgery within the 90 days before joining.
• People who have used immune-modifying medications within the 6 months before joining.
• People with significant active skin conditions such as rash, eczema, psoriasis, or hives.
• People with an autoimmune disease (such as lupus or multiple sclerosis) that requires ongoing treatment to suppress the immune system.
• People with a known history of a serious (CDC Stage 3) HIV-related opportunistic infection.
• People with any history of an HIV-related cancer.
• People with a known or suspected active, or untreated latent, tuberculosis infection.
• People with an active or recent cancer not related to HIV.
• People who have had a serious illness requiring treatment or hospitalisation within 90 days before joining.
• People with known resistance to HIV medications across two or more drug classes.
• People with a current or past history of cardiovascular disease related to hardening of the arteries.
• People with advanced liver disease.
• People who have used complementary or alternative medicines within 14 days before joining.

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