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 aged 18 to 60 years old at the time of screening
• People who are able to give written consent, including agreeing to long-term follow-up
• People who are willing and able to attend scheduled visits and provide blood samples
• People who started HIV treatment (ART) within six months of their estimated time of first HIV infection, where that timing is confirmed by one of several specific lab test results (confirm with trial site for which test result applies)
• OR, people who started HIV treatment during an early stage of infection, with a strong immune cell count (CD4 above 500) and who have had undetectable HIV levels in their blood for at least one year while on treatment (one low-level blip below 500 copies/mL during that time is allowed)
• People whose HIV virus shows no signs of being resistant to the two antibody treatments used in this trial, based on genetic testing of the virus
• People who test negative for Hepatitis B, Hepatitis C, or related markers
• People with no major other health conditions
• People whose lowest-ever immune cell count (CD4) was above 250, for those confirmed to have been diagnosed during early HIV infection
• People whose current immune cell count (CD4) is above 500, or whose CD4 to CD8 immune cell ratio is greater than 1
• People currently on a specific type of HIV treatment regimen (integrase inhibitor or boosted protease inhibitor based); those who were previously on a different type (NNRTI) must have switched at least four weeks before joining the trial
• People with a healthy enough haemoglobin level (at least 12 g/dL for males, at least 11 g/dL for females)
• People who weigh at least 50 kg
• People who have been vaccinated against COVID-19 at least four weeks before enrolling
• People with the ability to become pregnant must agree to use reliable contraception or complete abstinence, starting at least two weeks before the first infusion and continuing for 20 months after the last infusion

Who may not be able to join:

• People with a history of heart disease, heart attack, angina, or stroke
• People with any current or past history of cancer, except for a type of common skin cancer (squamous cell skin cancer)
• People with an active opportunistic infection, or other serious health condition that is present or likely to develop during the trial (such as conditions affecting nutrient absorption or autoimmune diseases)
• People who have a medical reason preventing them from taking standard recommended HIV combination treatments
• People co-infected with HTLV-1 (a different virus)
• People who test positive for COVID-19 by a nose/throat swab test within 72 hours before the randomisation or dosing visit
• People considered at high risk of severe COVID-19, who may have been identified as vulnerable or shielding under NHS guidance, in the opinion of their doctor
• People currently using or planning to use medicines that suppress the immune system (inhaled or skin-applied steroids are allowed)
• People already taking part in another clinical trial of an experimental treatment, or in a non-observational study that requires extra blood draws
• People with a history of severe allergic reactions to antibody infusions, or known sensitivity to either of the two antibody treatments used in this trial or their ingredients
• People who are planned to receive intravenous immunoglobulin or other antibody-based treatments during the trial period
• People with significantly abnormal blood test results at screening, including signs of serious liver damage, liver scarring, or certain abnormal readings for liver enzymes, kidney function, protein in the urine, or blood clotting (confirm specific values with trial site)
• People with signs of organ problems or other significant abnormalities found during a physical examination or vital signs check, in the opinion of the investigator
• People with active alcohol or substance use that, in the investigator's opinion, would make it difficult to follow the study requirements
• People without sufficient vein access to allow the required blood draws throughout the study
• People where there is concern they may not take precautions to prevent passing on HIV to others during the period of the trial when treatment is interrupted
• People who are pregnant or breastfeeding

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