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), confirmed by the NCI Laboratory of Pathology.
• People who have at least five measurable KS skin lesions that have not been treated with local radiation, surgery, or injected chemotherapy (depending on which group within the trial a person is assigned to), and/or measurable disease detectable by standard imaging criteria.
• People who are HIV-positive or HIV-negative may be considered.
• People who are able to swallow tablets or capsules.
• People whose blood counts and organ function meet certain minimum levels — including white blood cells, platelets, haemoglobin, liver function, kidney function, and heart function — as determined by blood tests and a heart scan (confirm with trial site for exact values).
• People who have received at least one prior systemic (whole-body) treatment for KS that either stopped working, showed limited response, or caused the disease to progress (this applies to certain groups within the trial).
• People in certain groups who have not previously received systemic treatment for KS (confirm with trial site which group applies).
• People with advanced-stage KS (Stage T1) that involves swelling, ulcerated lesions, extensive lesions in the mouth, and/or internal organ involvement (for one specific group within the trial).
• People who previously received the study drug abemaciclib and showed at least a partial response to it (for one specific group within the trial), provided they were previously enrolled in an earlier group of this trial and did not stop treatment due to a serious side effect from abemaciclib.
• People aged 18 years or older.
• People with a general health and activity level rated as reasonably functional, as assessed using standard medical scales (confirm with trial site).
• People living with HIV who are on effective antiretroviral therapy (ART) — medication that controls HIV — for at least 8 weeks before joining, with no signs of KS improvement over the most recent 4 weeks.
• People willing to continue taking their antiretroviral therapy as prescribed.
• People with a history of hepatitis B who have an undetectable hepatitis B virus level while on appropriate treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable hepatitis C virus level.
• People without any current severe, uncontrolled infections (bacterial, viral, or fungal).
• People with a history of heart-related conditions whose heart function is assessed as Class 2B or better using a standard heart health classification system.
• People who are able to use highly effective contraception (such as an intrauterine device, hormonal contraception, surgical sterilisation, or abstinence) during the trial and for up to 4 months after finishing the study drug — this applies to people who could become pregnant.
• People who are able to father a child must agree to use effective contraception (such as a barrier method, surgical sterilisation, or abstinence) during the trial and for up to 4 months after finishing the study drug, and their partners of childbearing potential should also use effective contraception.
• People who are currently breastfeeding must be willing to stop breastfeeding if enrolled and treated with abemaciclib, due to potential risks to the infant.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy or immunotherapy within the 3 weeks before joining the trial.
• People who have had radiotherapy and have not yet fully recovered from its immediate side effects, or where fewer than 14 days have passed since completing radiotherapy.
• People who still have ongoing side effects (above a mild level) from previous cancer treatment, with the exception of hair loss or nerve-related symptoms.
• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who have had a severe allergic reaction to a drug that is chemically similar to CDK inhibitors (the class of drug being studied).
• People taking certain medications — specifically strong or moderate inhibitors of a liver enzyme called CYP3A4 — unless appropriate dose adjustments are made (confirm with trial site).
• People with a serious or uncontrolled illness that, in the treating doctor's judgement, would make participation unsafe or not appropriate.
• People with active KSHV-associated multicentric Castleman disease, a related inflammatory condition called KSHV-associated inflammatory cytokine syndrome, or a cancer called primary effusion lymphoma.
• People with a mental health condition or personal circumstances that would make it difficult to follow the trial requirements.
• People who are currently pregnant.
• People with interstitial lung disease (a group of conditions that cause scarring or inflammation in the lungs).

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