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 been diagnosed with Kaposi Sarcoma (KS) — a type of cancer — confirmed by a specific laboratory, whether or not they have had previous KS treatment
• People who are living with HIV
• People aged 18 or older
• People who have at least five measurable KS skin lesions that have not previously been treated with local radiation, surgery, or direct lesion injections (which would make it harder to measure treatment response)
• People whose KS has spread to internal organs but whose related symptoms are mild (Grade 2 or lower on a standard medical scale) and do not require urgent treatment
• People who either have not had previous systemic (whole-body) KS treatment, or who have had it but whose KS has stopped responding, come back, worsened, or not responded well enough
• People who have been on effective HIV antiretroviral therapy (ART — medication to control HIV) for at least 2 months before starting the study drug, whose HIV levels in the blood are very low (100 copies/mL or fewer), and whose KS is still present and affecting quality of life despite being on ART
• People whose general health and ability to carry out daily activities meets a certain level (confirm with trial site)
• People whose blood counts and organ function meet minimum levels, including white blood cells, platelets, red blood cells, and liver function (confirm with trial site for specific values)
• People whose immune cell count (CD4 T-cell count) is 350 cells per microlitre or below
• People who are willing to also enrol in a related research study about tumour characteristics
• People with a long-term hepatitis B infection, as long as they are already on antiviral treatment that keeps the virus under control
• People who have had hepatitis C in the past, as long as the hepatitis C virus is no longer detectable in their blood
• People who are able to become pregnant, or men who could father a child, who agree to use an effective form of contraception from when they start the trial, throughout treatment, and for up to 4 months after finishing the study drug
• People who are currently breastfeeding and are willing to stop breastfeeding from the start of treatment until 4 months after the last dose
• People who are able to understand and willing to sign a consent form agreeing to take part

Who may not be able to join:

• People who still have significant side effects (above Grade 1 on a standard medical scale) from a previous immune-related treatment — note: people whose thyroid is managed with standard thyroid medication may still be eligible
• People who have had a severe allergic or hypersensitivity reaction to certain types of laboratory-made antibody treatments (confirm with trial site for specific types)
• People who have received chemotherapy, radiotherapy, or other KS-directed treatment (other than HIV medication) within 2 weeks before starting the study drug
• People who have taken certain medications that suppress or stimulate the immune system within 2 weeks before starting the study drug — note: some short-term, low-dose exceptions may be allowed, and certain inhaled or topical medications are permitted (confirm with trial site)
• People with a history or significant risk of autoimmune disease — though some mild or symptom-free immune-related findings may be acceptable (confirm with trial site)
• People with a history of certain lung conditions, including lung scarring, lung inflammation, or other related conditions, or those who show signs of active lung inflammation on a chest X-ray — note: scarring from past radiation treatment to the lung may be acceptable
• People who have previously had a stem cell transplant from a donor, or any other organ transplant
• People who have another cancer that currently requires active treatment
• People with active tuberculosis (TB)
• People who test positive for pregnancy at the screening stage
• People who have received certain other medications that are not allowed in this trial within 4 weeks before starting the study drug (confirm with trial site for the specific list)
• People with a serious uncontrolled illness that would make it difficult to follow the study requirements

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