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 who have a confirmed HIV-1 diagnosis.
• People whose HIV viral load (the amount of virus in the blood) was above 400 copies/mL before they started HIV treatment.
• People who weigh at least 50 kg.
• People who are willing and able to give their informed consent and to continue their HIV treatment throughout the study.
• People who have been on combination HIV treatment for at least 2 years, and on the same treatment regimen for at least 4 weeks before the screening visit.
• People whose HIV viral load has been undetectable (below 50 copies/mL) for more than 2 years, confirmed on at least 2 separate tests, and is also below 50 copies/mL at screening. A single result between 50–500 copies/mL during that period does not automatically rule out participation, as long as the next test result was below 50 copies/mL.
• People whose CD4+ T cell count (a measure of immune system health) is above 500 cells/μL at screening.
• Women who cannot become pregnant — either because they have gone through menopause (no periods for 12 months and aged 45 or older) or because they have had their tubes tied, a hysterectomy, or both ovaries removed.
• Women who could become pregnant, provided they have a negative pregnancy test at both the screening visit and Day 0, and agree to use a reliable contraception method from 14 days before the first treatment until the end of the study. Accepted methods include complete abstinence from penile-vaginal intercourse, double barrier methods (such as condom plus spermicide or diaphragm), an IUD with a published failure rate below 1% per year, a male partner who has had a confirmed vasectomy and is the person's only partner, approved hormonal contraception (noting that some HIV medications may reduce how well hormonal contraceptives work, in which case non-hormonal methods would be recommended), or any other method with a published failure rate below 1% per year. Whichever method is used must be used consistently, and all women of childbearing potential must be willing to take urine pregnancy tests as required by the study schedule.
• All participants must agree not to try to conceive (including attempting pregnancy, sperm donation, IVF, or egg donation) during the study.
• Heterosexually active men who either have confirmed surgical sterilisation before entering the study, or whose partner uses a contraception method with a failure rate below 1% per year (such as hormonal contraception, an IUD, or surgical sterilisation) from the first treatment until the end of the study, as long as their viral load remains below 20 copies/mL.
• Participants enrolling in Singapore must agree to follow the Infectious Diseases Act, particularly the section relating to HIV infection and sexual activity (Part 4, Section 23).

Who may not be able to join:

• People who have an active, known, or suspected autoimmune condition, including (but not limited to) inflammatory bowel disease, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, lupus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insufficiency, thyroid problems, autoimmune thyroiditis, sarcoidosis, or vitiligo.
• People with a history of interstitial lung disease (scarring or inflammation of the lungs).
• People with a history of chronic obstructive pulmonary disease (COPD).
• People with Type 1 diabetes.
• People with a currently active cancer, or a history of cancer that required chemotherapy or surgery in the past 24 months. An exception is made for certain localised skin cancers (squamous cell or basal cell carcinoma) that have been surgically removed.
• People who have had a solid organ transplant. People who have had a corneal transplant may be considered after discussion with the study's principal investigator.
• People with active tuberculosis (TB) or a history of TB that required treatment.
• People who have had an HIV-related opportunistic infection (a serious infection that occurs because the immune system is weakened) within the last few years before entering the study (confirm exact timeframe with trial site).
• People with a history of immune reconstitution inflammatory syndrome (IRIS), a condition where the immune system overreacts when HIV treatment begins.
• People who have a serious ongoing bacterial, fungal, or viral infection (other than HIV) that required treatment with systemic medications within the 30 days before entering the study.
• People with an immune deficiency that is not caused by HIV.
• People who have taken part in a clinical trial of an experimental drug or device within the 6 months before entering the study.
• People who have received treatment for hepatitis C within the 6 months before entering the study.
• People who have previously been treated with an immune checkpoint inhibitor (a type of medication used in cancer treatment that affects the immune system).
• People who have previously received immunoglobulin (IgG) therapy (a treatment using antibodies from donated blood).
• People who have used immune-modifying medications (such as interleukins, interferons, or cyclosporine), systemic chemotherapy, experimental vaccines, or other investigational treatments within the 60 days before entering the study, or who plan to use these during the study. People taking low, stable doses of steroid medications (such as prednisolone 10 mg/day or equivalent), or inhaled or topical steroids, are not excluded.
• People who are on any other current or previous treatment that the study investigators consider would make them unsuitable or could affect the study results.
• People with severe liver disease, classified as Child-Pugh Class C (confirm details with trial site).
• People with unstable liver disease, indicated by conditions such as fluid build-up in the abdomen, confusion caused by liver disease, blood clotting problems, low albumin, varicose veins in the oesophagus or stomach, or ongoing jaundice. People with known bile duct abnormalities are also excluded, except for Gilbert's syndrome or gallstones without symptoms.
• People who plan to change their HIV treatment regimen during the study period.
• People whose alcohol or substance use, in the opinion of the study investigators, would prevent them from following the study procedures properly.
• People with active, serious psychiatric conditions that, in the opinion of the study investigators, make participation unsuitable.
• People with any other active, clinically significant medical condition not already covered above.
• Women who are pregnant or breastfeeding, or women who could become pregnant but are unwilling or unable to use an accepted contraception method as described in the inclusion criteria.
• Men who are capable of fathering a child but are unwilling or unable to use an accepted contraception method as described in the inclusion criteria.
• For people in Cohort A (a sub-group involving fine needle biopsy), additional exclusion criteria apply, including certain abnormal blood clotting test results, very low platelet counts, chronic poor circulation in the lower legs, lower limb lymphoedema (swelling caused by blocked lymph vessels), allergy to local anaesthetic, or a blood clotting disorder.
• People whose blood test results fall outside acceptable ranges, including: low haemoglobin (below 14.0 g/dL for men or 12.0 g/dL for women); low neutrophil count (a type of white blood cell); low platelet count; elevated liver enzymes (AST or ALT); elevated bilirubin levels (with different thresholds depending on HIV medication used); a positive or abnormal TB screening test (IGRA); thyroid hormone levels outside normal range; presence of certain antibodies linked to thyroid or autoimmune conditions (anti-TPO or anti-GAD antibodies); certain abnormal immune markers (ANA above 1:80); abnormal early morning cortisol levels (a stress hormone — women on oestrogen-containing contraception may be able to repeat this test); fasting blood sugar above 7.0 mmol/L (unless already diagnosed with Type 2 diabetes); a positive hepatitis B surface antigen test; or a positive hepatitis C antibody test without confirmed clearance of the infection.

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