Early Phase 1 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 plasmablastic lymphoma, confirmed through a tissue biopsy and specific laboratory testing of the cells.
• People with stage II, III, or IV disease, or stage I disease where the tumour is larger than 7.5 cm or a specific blood marker (LDH) is elevated.
• People whose HIV status is known — both HIV-positive and HIV-negative people may be eligible, though the trial limits HIV-negative participants to a maximum of 7 enrolled places.
• HIV-positive participants must have documentation of their HIV diagnosis or treatment confirmed through medical records, prescriptions, or an FDA-approved HIV test.
• HIV-negative participants must have a negative result on an FDA-approved HIV screening test.
• People whose disease can be measured on a CT or PET scan (at least one area of disease measuring 1.5 cm or more), or whose disease is detectable only in the bone marrow.
• People who are reasonably well and able to care for themselves, based on a standard medical rating scale (ECOG score of 0, 1, or 2).
• People whose blood counts meet minimum levels — specifically, a white blood cell type called neutrophils at or above 1,000 cells/mcL, and platelets at or above 75,000 cells/mcL (lower levels may be acceptable if caused by lymphoma in the bone marrow).
• People whose liver function blood test results fall within acceptable ranges as determined by the trial site.
• People whose kidney function is within acceptable levels, based on blood tests or a calculated kidney function score.
• People whose heart is pumping adequately, with a heart pump function (ejection fraction) of at least 45%, confirmed by a heart scan.
• HIV-positive participants must have a CD4 immune cell count of at least 100 cells/mL.
• HIV-positive participants must not have had a serious HIV-related infection (called an AIDS-defining opportunistic infection) in the past year.
• HIV-positive participants must currently be on, or agree to start, effective HIV treatment (antiretroviral therapy).
• People who are able to use reliable contraception (hormonal or barrier methods, or abstinence) throughout the trial and for 90 days after treatment ends — this applies to people who could become pregnant and to men with partners who could become pregnant.
• People who are willing and able to give written informed consent to participate.

Who may not be able to join:

• People who have received chemotherapy or radiation for this lymphoma before, with limited exceptions: one prior cycle of standard combination chemotherapy (such as EPOCH or CHOP-like treatment) starting between 21 and 28 days before the trial begins may be permitted; or one prior limited course of cyclophosphamide and/or steroids to improve overall health before starting the trial (confirm specific timing details with the trial site).
• People currently taking part in another clinical trial involving an experimental treatment.
• People who have received certain chemotherapy drugs called anthracyclines (such as doxorubicin) within the last two years — some exceptions may apply depending on the specific drug used and heart function results (confirm with trial site).
• People who have previously received the drug daratumumab for any reason.
• People currently taking certain medications that strongly interact with the study drug, including cobicistat, indinavir, ritonavir, or other strong CYP3A4 inhibitors — a switch to alternative medications at least one week before starting the trial may be required (confirm with trial site).
• People with significant nerve damage in their hands or feet (peripheral neuropathy rated grade 3 or higher, or nerve pain rated grade 2 or higher).
• People whose expected survival is less than 2 months.
• People with cancer that has spread to the brain from a solid tumour.
• People with known or suspected lymphoma affecting the brain tissue or spinal cord, or with symptoms of lymphoma in the fluid surrounding the brain or spine — people with lymphoma in that fluid but no symptoms may still be eligible (confirm with trial site).
• People who test positive for active hepatitis B infection (a positive HBsAg test). People with past hepatitis B infection may need further blood testing; those with detectable hepatitis B virus in the blood will not be eligible (some exceptions apply for people with evidence of prior vaccination only).
• People with hepatitis C antibodies who also have evidence of liver scarring (cirrhosis).
• People with a known allergy or sensitivity to daratumumab or similar drugs, or to any other medications used in this trial.
• People with serious uncontrolled illnesses, including active infections, uncontrolled heart failure, unstable chest pain, irregular heart rhythms, or mental health or social circumstances that would make following the trial requirements difficult.
• People who are pregnant or breastfeeding — a pregnancy test is required within 7 days before starting treatment for people who could become pregnant.
• People who, in the opinion of the trial investigator, are unable to follow the trial requirements or provide informed consent.
• People with serious ongoing non-cancer illness or active infection that could interfere with the trial, in the opinion of the investigator.
• People who have had major surgery (other than diagnostic procedures) within 4 weeks before joining the trial — note that spleen removal surgery is not considered a reason for exclusion.
• People who have had a heart attack within the past 6 months, or who have significant heart conditions including moderate-to-severe heart failure, uncontrolled chest pain, serious heart rhythm problems, or signs of active heart disease on an ECG.
• People with chronic obstructive pulmonary disease (COPD) where breathing tests show lung function below 50% of normal, or people with moderate-to-severe asthma, uncontrolled asthma of any type, or a history of asthma within the last 2 years — people with mild, well-controlled asthma may still be eligible (confirm with trial site).
• People who have had another cancer in the past, unless treatment for that cancer finished at least 2 years ago with no signs of it returning, or unless that other cancer is stable and does not currently need treatment.

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