Phase 1 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 between 18 and 55 years of age.
• People who are able to visit a participating clinic and are willing to stay in the study for its full duration.
• People who understand the study and are willing to give their informed consent to participate.
• People who agree not to join another experimental study until their final required clinic visit.
• People who are in good overall health, based on medical history, a physical exam, and screening blood tests.
• People who are willing to receive their HIV test results.
• People who are willing to discuss personal HIV risk and receive HIV prevention counselling.
• People whom clinic staff judge to have a low risk of getting HIV, and who agree to avoid higher-risk behaviours through to the last clinic visit.
• People with haemoglobin levels of at least 11.0 g/dL (for women) or at least 13.0 g/dL (for men).
• People with a white blood cell count between 2,500 and 12,000 cells/mm³.
• People with a white blood cell breakdown (differential) that is normal or considered acceptable by clinic staff.
• People with a platelet count between 125,000 and 550,000 cells/mm³.
• People with liver enzyme (ALT) levels below 1.25 times the upper limit of normal for the testing laboratory.
• People with kidney function (creatinine) levels below 1.1 times the upper limit of normal for the testing laboratory.
• People who test negative for both HIV 1 and HIV 2.
• People who test negative for hepatitis B surface antigen.
• People who test negative for hepatitis C antibody, or who test negative on a follow-up hepatitis C PCR test if the antibody test is positive.
• People whose urine protein test shows negative or only a trace amount.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first study treatment. (Women who have had a full hysterectomy, both ovaries removed, both fallopian tubes removed, or who have experienced menopause — defined as no periods for at least one year — do not need pregnancy testing.)
• Women who could become pregnant must agree to use effective birth control for any sexual activity that could lead to pregnancy, starting at least 21 days before joining the study and continuing through the last study visit.
• Women who could become pregnant must also agree not to attempt pregnancy through methods such as egg retrieval, artificial insemination, or in vitro fertilisation, starting at least 21 days before joining the study and continuing through the last clinic visit.

Who may not be able to join:

• People who received blood products within 120 days before the first study dose, unless the safety review team approves earlier enrolment.
• People who took any experimental research drug within 30 days before the first study dose.
• People who weigh less than 35 kg or more than 115 kg.
• People who plan to join another study involving an experimental product, or any study that requires non-Network HIV antibody testing, during this study.
• People who are pregnant or breastfeeding.
• People who have previously received an HIV vaccine as part of a vaccine trial. (Those who received only a placebo or control in a previous trial will be assessed case by case by the safety review team.)
• People who received any non-HIV vaccine within 14 days before enrolment, or who plan to receive one within 14 days after enrolment. (An exception applies for the ACAM2000 smallpox vaccine — confirm details with the trial site.)
• People who have previously received humanised or human monoclonal antibody treatments, whether approved or experimental.
• People who have previously received monoclonal antibodies that specifically target HIV.
• People who are receiving allergy shots within 30 days before the first study dose, or who have allergy shots scheduled within 14 days after the first dose.
• People who have taken immune-suppressing medicines within 30 days before the first study dose. (Some exceptions apply for certain nasal sprays, inhaled steroids, mild topical steroids, and short courses of low-dose oral or intravenous prednisone — confirm details with the trial site.)
• People with a history of serious allergic reactions to any components of the study products, including anaphylaxis or symptoms such as hives, breathing difficulties, swelling, or abdominal pain.
• People who received immunoglobulin treatment within 60 days before the first study dose.
• People with an autoimmune disease that is not mild, stable, and uncomplicated. Mild and stable cases not requiring immune-suppressing medication may be considered at the investigator's discretion.
• People with a condition that causes a weakened immune system (immunodeficiency).
• People with a significant medical condition, abnormal exam finding, or abnormal lab result that could affect the immune system, require immune-affecting medicines, make injections or blood draws unsafe, require ongoing active medical management, or produce symptoms that could be confused with reactions to the study product.
• People with a medical condition, skin condition, social situation, or job requirement that, in the investigator's judgement, would interfere with safely completing the study or giving informed consent.
• People with a psychiatric condition that would prevent them from following the study requirements — specifically those with psychosis, a current risk of suicide, or a suicide attempt within the past three years.
• People who are currently receiving treatment for tuberculosis.
• People with asthma that is more than mild and well controlled.
• People with type 1 or type 2 diabetes. (Exceptions apply for type 2 diabetes controlled by diet alone, or a past history of gestational diabetes only.)
• People with high blood pressure (hypertension).
• People with a diagnosed bleeding disorder.
• People with a current cancer diagnosis. (Exceptions may apply for certain surgically removed cancers with a very low risk of return during the study period — confirm with the trial site.)
• People with a seizure disorder who have had any seizure in the past three years, or who have used seizure-related medicines at any point in the past three years.
• People without a functioning spleen.
• People with a history of widespread hives, swelling (angioedema), or anaphylaxis. (An exception applies if the reactions were due to a known trigger and no reactions have occurred for at least five years, indicating the trigger has been successfully avoided.)

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