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:

General entry (Step 1 — for younger children):

• People who were previously enrolled in the EIT/Tatelo or Moso Cohort Study
• People who have been taking prescribed HIV treatment (ART) for at least 24 weeks before joining, based on records and reports
• Children aged 24 weeks up to and including 12 years old at the time of enrollment
• Children whose HIV levels in the blood have been very low (below 40 copies/mL) for at least 24 weeks, with a recent confirmed test within the last 30 days showing the same (for one sub-group, a slightly higher threshold of below 200 copies/mL for 24 weeks applies, with a recent test below 40 copies/mL)
• Children with a normal body temperature and no signs of current illness at the time of joining
• Children with blood test results (for red blood cells, white blood cells, platelets, liver enzymes, and kidney function) that fall within acceptable ranges, based on tests done within 30 days before joining
• Female participants who are able to become pregnant must have a negative pregnancy test from a sample taken within 5 days before enrollment
• People who are expected to be available for all study visits and to follow the study requirements throughout the study
• People who are not currently in another study involving an experimental treatment, and are not expected to join one during this trial (participation in the EIT/Tatelo or Moso cohort studies is allowed)
• Children whose parent or legal guardian is willing and able to give written permission for their participation, and children aged 7–17 who are willing and able to give their own written agreement to take part

Moving to Step 2:

• People who have reached at least the 24-week visit in Step 1
• People whose HIV virus was found to be sensitive to at least 2 of the 3 antibody treatments being studied, or who had specific negative test results in the absence of that sensitivity data
• People whose HIV levels have stayed very low (below 40 copies/mL) throughout Step 1 and for at least 24 weeks before starting Step 1

Moving to Step 3 (from Step 1, Step 2, or joining directly):

• People who have completed at least 24 weeks in Step 1 or Step 2 with consistently very low HIV levels throughout
• People who have had very low HIV levels for at least 96 weeks (or since 24 weeks of age, for very young children)
• People whose HIV virus has been shown to have specific characteristics suggesting it may be inactive or absent, based on specialised blood tests (confirm with trial site)
• People approved to enter Step 3 by the study's Clinical Management Committee
• For those joining Step 3 directly: people previously enrolled in the EIT/Tatelo, Moso, or BHP Adolescent Cohort Study, aged 96 weeks to 25 years
• For those joining Step 3 directly: people on prescribed HIV treatment with very low or undetectable HIV levels for at least 96 weeks or, in some cases, at least 10 years (depending on virus status)
• Female participants who are able to become pregnant must have a negative pregnancy test from a sample taken within 5 days before enrollment (for direct Step 3 entry)
• Female participants who are able to become pregnant and are sexually active in ways that could lead to pregnancy must be willing to use two forms of contraception during the study — one of which must be a highly effective method (such as an IUD, implant, hormonal injection, combined pill, patch, or vaginal ring), and the second must be a barrier method; the highly effective method must be started before enrollment
• Female participants who are able to become pregnant must not currently be breastfeeding and must not intend to breastfeed during the study
• People who are sexually active must be willing to receive counselling and to use condoms to help prevent HIV transmission
• People who are not currently in another study involving an experimental treatment, and are not expected to join one during this trial (participation in EIT/Tatelo, Moso, or BHP Adolescent cohort studies is allowed)
• People who are willing and able to give written consent, or whose parent or legal guardian is willing to give permission, with assent from children aged 7–17

Step 4:

• People who previously entered the study at Step 1 or Step 3 and have completed a prior study step, regardless of the reason for ending that step

Who may not be able to join:

• People who have active tuberculosis (suspected or confirmed) or any active cancer
• People who test positive for hepatitis B surface antigen (a marker of hepatitis B infection)
• People who have received, or who need, immunoglobulin-based treatments or long-term (more than 14 days) systemic steroid treatment within 30 days before joining
• People who have any other significant medical condition that the site investigator believes could make participation unsafe, affect the study results, or interfere with the study's goals
• Children entering Step 1 or Step 2 who weigh less than 5 kg or more than 115 kg
• People entering Step 3 directly who have taken certain HIV medications known as NNRTIs (including efavirenz, nevirapine, or rilpivirine) within 14 days before starting Step 3

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