Phase 1 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For Groups 1 and 2 (Step 1):

• People who are Thai nationals aged 18 to 60 years old who can read and write Thai
• People who are willing and able to give written consent to participate
• People who have a confirmed HIV-1 infection and who started HIV treatment (ART) during the early stage of infection
• People who have been on HIV treatment continuously (with no break of 7 days or more) for at least 48 weeks
• People currently taking an integrase inhibitor-based HIV treatment (not a long-acting injectable type), with no changes to that treatment in the past 8 weeks, and with at least one recorded undetectable viral load since the last treatment change
• People who are in good general health based on medical history, physical examination, and lab tests, as judged by the study doctor
• People whose blood test results at screening meet specific minimum levels for immune cells (CD4 count at or above 400 cells/mm³), white blood cells, red blood cells, platelets, kidney function, liver enzymes, and bilirubin, and who test negative for hepatitis C (confirm with trial site)
• People who have had an undetectable HIV viral load (under 50 copies/mL) for at least 48 weeks, with no history of treatment failure, and only very limited and specific exceptions for minor fluctuations in viral load (confirm with trial site)
• People whose HIV virus shows no resistance to the study antibodies VRC07-523LS or PGDM1400LS based on a sensitivity test
• People who are not pregnant at screening (if there is any possibility of pregnancy)
• People who are able to become pregnant and agree to use two forms of contraception during the study if engaging in sexual activity that could lead to pregnancy
• People who agree to use a condom during the study to prevent HIV transmission and unintended pregnancy in a partner, from screening until the end of the study or until viral suppression is confirmed
• People who agree to use a condom, abstain from sex, or ensure their partner uses pre-exposure prophylaxis (PrEP) consistently during the treatment break period and until HIV levels are undetectable again
• People who pass a test showing they understand the study (confirm with trial site for details)
• People who are willing to stop and restart HIV treatment according to the study schedule
• People who are willing to follow all study rules and attend all visits for the full duration of the study

For Group 3 (Step 2):

• People who are Thai nationals aged 18 to 60 years old who can read and write Thai
• People who are willing and able to give written consent to participate
• People whose blood test results meet specific minimum levels for immune cells (CD4 count above 200 cells/mm³), white blood cells, red blood cells, platelets, kidney function, liver enzymes, and bilirubin, and who have a detectable HIV viral load above 1,000 copies/mL and test negative for hepatitis C (confirm with trial site)
• People who are not pregnant at screening (if there is any possibility of pregnancy)
• People who are able to become pregnant and agree to use two forms of contraception during the study if engaging in sexual activity that could lead to pregnancy
• People who agree to use a condom to prevent HIV transmission and unintended pregnancy in a partner, from screening until the end of the study or until viral suppression is confirmed
• People who agree to use a condom, abstain from sex, or ensure their partner uses PrEP consistently during the treatment break period and until HIV levels are undetectable again
• People who pass the study understanding test
• People who are willing to stop and restart HIV treatment according to the study schedule
• People who are willing to follow all study rules and attend all visits for the full duration of the study
• People who are in the very early stage of HIV-1 infection, confirmed by specific testing methods within a defined short window after a negative HIV test (confirm with trial site for exact definitions)
• People who have not used any HIV treatment in the past 30 days

For all groups to move to the treatment break stage (Step 3):

• People who have received all scheduled study products or placebos as required
• People whose HIV viral load is undetectable (under 50 copies/mL) at the last Step 2 visit
• People whose CD4 immune cell count is at or above 400 cells/mm³ at the last Step 2 visit
• People who have not had any serious HIV-related illness (CDC Category C event) since joining the study
• People who test negative for hepatitis B surface antigen at the last Step 2 visit
• People who test negative for hepatitis C at the last Step 2 visit
• People who are not pregnant at the start of Step 3 (if there is any possibility of pregnancy)
• People who agree to use two forms of contraception during Step 3 if engaging in sexual activity that could lead to pregnancy
• People who agree to use a condom, abstain from sex, or ensure their partner uses PrEP consistently during the treatment break and until HIV levels are undetectable again
• People who are willing to participate in the treatment break phase for up to 50 weeks and to restart HIV treatment according to study guidelines

Who may not be able to join:

For Groups 1 and 2 (Step 1):

• People who weigh less than 50 kg or more than 115 kg
• People who carry a specific gene variant (HLA B*57:01) that is linked to natural control of HIV
• People who have a medical reason that prevents them from receiving injections into muscle, having an intravenous line placed, or having blood drawn
• People who have had a serious illness requiring medical treatment or hospitalisation in the 90 days before joining
• People with any significant ongoing or past medical condition that the study doctor believes would make participation unsafe, such as heart disease, lung disease, liver disease, kidney disease, bleeding disorders, autoimmune conditions, cancer, poorly controlled asthma, active tuberculosis, or seizure disorders
• People with active or chronic hepatitis B infection
• People who have been treated for hepatitis C or who have a detectable hepatitis C viral load in the past 6 months
• People who have received a licensed or emergency-use vaccine in the 4 weeks before screening, or who plan to receive a live vaccine within 4 weeks, or any other licensed vaccine within 2 weeks before or after any study product is given
• People who plan to receive a smallpox or Mpox vaccine within 12 weeks before or 2 weeks after either of the two MVA-based study vaccine doses
• People who have taken part in another clinical study involving an investigational agent within the 12 months before screening
• People who have previously received immunoglobulin (IgG) therapy (with some exceptions for those who received it as a preventive treatment more than 12 months before screening)
• People who have previously received a humanised or human monoclonal antibody treatment, whether approved or experimental (with some exceptions for COVID-19 monoclonal antibody treatment received more than 12 months before screening)
• People who have previously taken part in an HIV vaccine study or received experimental HIV prevention treatment, where they received or may have received an active product
• People who have used immune-modifying medications in the 6 months before joining, such as long-term oral steroids, immunosuppressants, cancer drugs, interferons, or chemotherapy (topical or inhaled steroids are not excluded)
• People with a known allergy or history of severe allergic reactions to vaccines, vaccine ingredients, or antibiotics such as neomycin, streptomycin, or gentamicin, or to egg products
• People who have had a severe allergic reaction including widespread hives, severe swelling, or anaphylaxis in the 2 years before joining
• People with a history of chronic hives needing daily treatment, or chronic or recurring eczema or atopic dermatitis
• People who have had their spleen removed
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a significant mental health condition or substance use issue in the past 12 months that the study doctor believes would affect safe participation

For Group 3 (Step 2) — additional exclusions beyond those listed above:

• People with a very low white blood cell count (absolute neutrophil count below 740 cells/mm³)
• People experiencing a severe acute HIV illness that required hospitalisation or that would prevent them from returning for follow-up visits

For all groups moving to the treatment break stage (Step 3):

• People who experienced treatment failure (two consecutive HIV viral loads above 1,000 copies/mL) after joining the study
• People who develop a new illness, medical finding, or lab result that the study doctor believes would make the treatment break unsafe
• People who received a specific type of HIV medication called a non-nucleoside reverse transcriptase inhibitor (NNRTI) within 60 days before the treatment break phase begins
• People who received long-acting injectable HIV treatments (such as long-acting cabotegravir or long-acting rilpivirine) at any point after joining the study
• People who missed three study visits in a row during Steps 1 or 2
• People who are pregnant or breastfeeding
• People with active drug or alcohol use that the study doctor believes would affect their ability to follow the study requirements

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