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:

To enter the first phase (Step 1):

• People who have recent medical records confirming a new HIV infection, based on specific combinations of HIV test results taken within the past few weeks (confirm exact testing combinations with trial site)
• People whose recent blood test results show healthy enough levels of white blood cells, red blood cells, platelets, and kidney and liver function
• People who could become pregnant must have a negative pregnancy test taken within 24 hours before joining
• People who could become pregnant must agree to use two forms of contraception during this phase, one of which must be highly effective and one of which must be a barrier method (such as a condom)
• People who could get a partner pregnant must agree to use a barrier method of contraception during this phase
• People who are willing and able to use a barrier method or avoid sex with partners who could catch HIV, or whose HIV status is unknown, throughout later phases of the study
• People aged 18 to 70 years old
• People who are willing and able to start HIV treatment (antiretroviral therapy, or ART) at the time of joining
• People who are willing and able to attend all required study visits, including during a planned period without HIV treatment
• People who are willing and able to give informed consent to participate

To enter the second phase (Step 2):

• People whose test results show no active hepatitis B infection, taken within 16 weeks before this phase
• People whose test results show no active hepatitis C infection, taken within 16 weeks before this phase
• People who received all planned study infusions (either the study antibodies or a placebo) during the first phase
• People whose HIV levels in the blood are very low (below 200 copies/mL), measured within 6 weeks before this phase
• People whose immune cell count (CD4+ T-cells) is at or above 450 cells/mm³, measured within 6 weeks before this phase
• People who could become pregnant must have a negative pregnancy test within 48 hours before entering this phase
• People who could become pregnant must agree to use contraception or avoid sex that could lead to pregnancy throughout this phase
• People who are willing and able to use a barrier method or avoid sex with partners who could catch HIV, or whose HIV status is unknown, throughout this phase
• People who are willing and able to temporarily stop taking HIV treatment during this phase
• People who have completed the first phase

To enter the third phase (Step 3):

• People who have not yet met the conditions that would require restarting HIV treatment
• People who have completed the second phase
• People who are willing to continue the planned treatment break
• People who could become pregnant must agree to use contraception or avoid sex that could lead to pregnancy throughout this phase
• People who are willing and able to use a barrier method or avoid sex with partners who could catch HIV, or whose HIV status is unknown, throughout this phase

To enter the fourth phase (Step 4):

• People who have met the conditions requiring HIV treatment to be restarted during the second or third phase, or who have completed the third phase and are not moving into a related follow-up study
• People who could become pregnant must agree to use contraception or avoid sex that could lead to pregnancy throughout this phase
• People who are willing and able to use a barrier method or avoid sex with partners who could catch HIV, or whose HIV status is unknown, until their HIV levels in the blood are undetectable after restarting treatment

Who may not be able to join:

At the start (Step 1):

• People who have previously received immunoglobulin (IgG) therapy, which is a treatment made from donated blood proteins
• People who have previously received a humanised or human monoclonal antibody treatment (whether approved or experimental), except for treatments related to COVID-19
• People who have had a severe allergic reaction — such as widespread hives, swelling, or anaphylaxis — in the past two years
• People with a history of ongoing hives (chronic urticaria) that require daily treatment
• People who have taken part in another experimental study and received an investigational treatment within the past 28 days
• People who have previously taken part in a study testing an experimental HIV vaccine or HIV prevention drug, particularly if they received an active product or are still unaware of whether they received the active product or a placebo
• People who have had a cancer (not related to HIV) that required chemotherapy or surgery in the past 36 months, or who are expected to need such treatment in the next 12 months
• People who have used certain immune-affecting medications within the past 6 months, including long-term steroid medicines, immune-suppressing drugs, anti-cancer drugs, or similar treatments (confirm full list with trial site)
• People who have used HIV treatment drugs for any reason, including for prevention (PrEP or PEP), within the past 60 days
• People whose drug or alcohol use, in the trial doctor's opinion, would make it difficult to follow the study requirements
• People with a known history of active hepatitis B or hepatitis C infection
• People with any serious ongoing or recent medical condition that, in the trial doctor's opinion, could affect their safety or their ability to follow the study requirements
• People with a history of or current heart or blood vessel disease, including previous heart attack, stroke, mini-stroke (TIA), angina, artery procedures, or related conditions
• People who are currently pregnant or breastfeeding
• People who weigh more than 115 kg
• People who are taking certain medications that interact with the HIV drugs used in this study, or who plan to take such medications during the study (confirm full list with trial site)
• People who do not have suitable veins for receiving infusions or having blood drawn

Before the second phase (Step 2):

• People whose HIV was not well controlled by treatment after the first 24 weeks of the study
• People who did not start HIV treatment during the first phase
• People who took certain types of HIV medications after joining the first phase, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) or long-acting injectable HIV treatments such as cabotegravir or rilpivirine injections
• People who received immunoglobulin therapy or immune-affecting medications after joining the first phase
• People who are found not to have HIV-1 infection
• People who were at a very early stage of HIV infection (called Fiebig stage VI) when they first joined — meaning their infection was already slightly more established at entry (confirm with trial site)
• People who missed three study visits in a row during the first phase
• People who have developed a new illness, medical condition, or abnormal test result that, in the trial doctor's opinion, would make a treatment break risky
• People who are pregnant or breastfeeding
• People whose drug or alcohol use, in the trial doctor's opinion, would make it difficult to follow the study requirements

Before the third phase (Step 3):

• People who are transferring to a related follow-up study called A5385
• People who had to restart HIV treatment during the second phase
• People who have developed a new illness, medical condition, or abnormal test result that, in the trial doctor's opinion, would make continuing the treatment break risky
• People whose drug or alcohol use, in the trial doctor's opinion, would make it difficult to follow the study requirements

Before the fourth phase (Step 4):

• People who are unwilling or unable to restart HIV treatment after meeting the conditions that require it

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