Infectious Diseases: Clinical Research Program

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

[email protected]

Eligibility

• Male or female at least18 years of age
• Diagnosed with HIV and under active care by licensed USA healthcare provider
• Receiving CAB+RPV LA injectable therapy monthly or every 2 months for at least 6 months but no longer than 18 months at study entry.
• PWH will be eligible if documented pattern of sub-optimal adherence on prior oral ART in the 12 months prior to CAB+RPV LA injectable therapy initiation.
• PWH who are virologically suppressed OR viremic (defined as viral load of HIV-1 RNA >200 copies/mL) at study entry.
• Inclusion/Exclusion Criteria: for matched healthy controls; PWH who have maintained virological suppression and had no adherence challenges with prior oral ART and/or PWH who have previously received CAB+RPV LA therapy as part of a clinical trial.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03635788

Principal Investigator

Rebecca Glassman, MD

Contact for Study Screening

[email protected]

Eligibility

• Male or female, Aged at least 50 years old at time of initiation of regimen of interest (index date).
• HIV-1 diagnosis
• Currently or previously prescribed either DTG/3TC or BIC/FTC/TAF alone to manage HIV-1 infection, initiated after market approval of DTG/3TC in the participant´s respective country
• Has at least 24 weeks of clinical data available after index date.
• Upon initiation participants must have been on a stable ART regimen for ≥3 months and have <200 copies/mL HIV-1 RNA up to 180 days prior to their index date (if more than one viral load (VL) assessment is available within the assessment window, the last available VL should be utilized)
• Exclusion Criteria
  • HIV-2 diagnosis
  • Previous treatment:
    • For BIC/FTC/TAF cohort participants, previous treatment with DTG+3TC or DTG/3TC
    • For DTG/3TC participants, previous treatment with BIC/FTC/TAF

Enrollment Status: Actively enrolling

Principal Investigator

Rebecca Glassman, MD

Contact for Study Screening

[email protected]

Eligibility

• At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg.
• Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid, nonrapid HIV immunoassay, and HIV RNA).
  Note: HIV-uninfected, based on HIV test results obtained at Screening and just prior to randomization at the Enrollment visit. All HIV test results from the Screening visit must be obtained and must all be negative/non-reactive. This includes testing for acute HIV infection, which must be performed within 14 days of Enrollment. In addition, at least one HIV test result using blood drawn at the Enrollment visit must be obtained prior to randomization into the study and must be negative/non-reactive. Individuals who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates that they are not HIV-infected. Those with any enrollment HIV test result positive will proceed through the HIV algorithm but will not be able to receive study product regardless of subsequent test results.
• Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months.
• Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening.
  Note: A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
• No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
• PARTICIPANT KEY CHARACTERISTICS:
  • Participants who have received oral PrEP (TDF/FTC; TAF/FTC), are eligible, but they must discontinue oral PrEP within 10 days of Day 1 visit.
• SEX:
  • Male or female at birth (transgender individuals are not excluded).
• INFORMED CONSENT:
  • Must be of legal age to consent to sexual intercourse and capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    For adolescents: Willing to provide written informed assent/consent for the study and/or able to obtain written parental/guardian informed consent;
    • If not of legal age or otherwise not able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.
    • If of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Willing and able to provide written informed consent for study participation.
• Exclusion Criteria
  • One or more reactive or positive HIV test results at Screening or Enrollment, even if HIV infection was not confirmed.
  • Participants who are breastfeeding or plan to become pregnant or breastfeed during the study.
  • Alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN).
  • Evidence of active Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (hBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of clinically relevant hepatitis within last 6 months.
  • Known history of liver cirrhosis with or without viral hepatitis co-infection.
  • Creatinine clearance of <30 mL/min/1.73 m2 via CKD-EPIcr_R (2022) method.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant’s participation in the study of an investigational compound.
  • Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 [triglycerides or lipid abnormalities]. A single repeat test is allowed during the Screening period to verify a result.
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment.
  • Participant is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the Medical Monitor is granted.
  • Presence of any history of allergy/sensitivity to any of the study drug.
  • Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06741397

Principal Investigator

Rebecca Glassman, MD

Contact for Study Screening

[email protected]

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

[email protected]