Infectious Diseases: Clinical Studies Open For Enrollment
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Eligibility
- Subject is 25 years of age or younger
- Suspected, probable, confirmed, or asymptomatic SARS-CoV-2 infection
- History of MIS-C
- Children 3 years of age or younger born in and out of the context of maternal SARS-CoV-2
- Infection during pregnancy
- Children/Young Adults with Post-Vaccine Myocarditis
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT05172011
Principal Investigator
Sheila Nolan, MD
Contact for Study Screening
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Eligibility
- Aged ≥12 years and ≥ 35 kg
- Type of Participant and Disease Characteristics
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL
- Plasma HIV-1 RNA >1 000 c/mL and <100 000 c/mL at Screening
- Evidence of insufficient virologic response to participant’s current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria
- <1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months
- Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART)
- Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs)
- Currently being treated with an oral ART regimen containing a second generation INSTI and/or boosted protease inhibitor or, has agreed with their HCP to switch to such a regimen as part of their SOC treatment, and will be able to do so no later than Day 1 if randomized to the control arm – specific regimen to be recorded at Screening
- Pregnancy, Sex and Contraceptive/Barrier Requirements
- POCBP must have a negative serum or urine pregnancy test at screening and on Day 1 (Refer to Section 10.4 for definition for POCBP)
- Exclusion Criteria
- HIV-1 Subtype A6, if known from historical result
- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert’s syndrome or asymptomatic gallstones)
- Individuals with both HIV and HBV will be excluded from participating in studies where they would not be able to receive appropriate therapy (e.g., tenofovir, lamivudine, or entecavir) for their HBV co-infection and therefore may be at risk of hepatitis B flare. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV DNA as follows:
- Participants positive for HBsAg are excluded
- Participants negative for HBsAb and negative for HBsAg but positive for HBcAb may be excluded based on the following consideration:
- Exclude if HBV DNA is detected [either < LLoQ, > ULoQ OR numerical value (i.e., between LLoQ and ULoQ)]
- Not excluded if HBV DNA is negative, not detected
- History of liver cirrhosis with or without hepatitis viral co-infection
- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1)
- Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder
- History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
- Participants who in the investigator’s judgment, pose a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk
- Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06694805
Principal Investigator
Rebecca Glassman, MD
Contact for Study Screening
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Eligibility
- Male or female, aged ≥ 18 years.
- Commercial laboratory confirmed infection with B. microti (positive B. microti PCR)
- Exhibiting clinical symptoms of babesiosis.
- Able and willing to give written informed consent.
- Able to take ARAKODA according to Prescribing Information.
- If female of reproductive age, must have a negative urine or serum pregnancy test and agree to use an acceptable method of birth control from the time of consent through 90 days after the last dose of tafenoquine.
- Have any of the following risk factors for relapsing disease: age >50 years, asplenia, B-cell depleting immunotherapy (e.g., rituximab) in the 18 months preceding enrollment, active hematologic malignancy (especially B cell lymphoma with or without splenectomy), solid organ or hematopoietic stem cell transplant, human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome (AIDS) with CD4 counts < 200 per μL of blood.
- Azithromycin, atovaquone, and/or clindamycin administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease, i.e. persistent babesiosis for which cure has not been achieved.
- Willing to initiate or continue a standard of care antimicrobial regimen according to the 2020 IDSA Guidelines on Diagnosis and Management of Babesiosis. Regimens that include quinine are strictly prohibited.
- Exclusion Criteria
- Have any contraindications for ARAKODA, including:
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
- Breastfeeding
- Psychotic disorder unmanaged with appropriate psychiatric medication or current psychotic symptoms
- Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines.
- Current or planned treatment with quinine while participating in the study.
- Any concomitant significant illness unrelated to babesiosis that, in the opinion of the investigator, might pose an unacceptable risk to the patient or the conduct of the study if the patient were enrolled.
- Any excluded concomitant medication as described in the ARAKODA package insert.
- The patient is unable to tolerate medication by the oral route.
- Have any contraindications for ARAKODA, including:
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06478641
Principal Investigator
Akira A. Shishido, MD
Contact for Study Screening