A trial to test the use of HIV drugs to treat neurofibromatosis type 2 (NF2) related tumours
- Conditions
- F2-related schwannomatosis (formerly Neurofibromatosis Type II) (NF2)Nervous System Diseases
- Registration Number
- ISRCTN10422213
- Lead Sponsor
- niversity Hospitals Plymouth NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 16
1. Written informed consent
2. Diagnosis of NF2-related schwannomatosis as defined using the 2022 criteria
3. Meningioma as identified by imaging
4. Over 18 years of age
5. Peripheral schwannomas under the skin (CS) biopsies amenable to biopsy
6. Karnofsky performance status >60%
7. Adequate bone marrow function within 28 days prior to the baseline visit: WBC >3.4 x 10e9/l, platelets >99 x 10e9/l
8. Adequate renal function within 28 days prior to the baseline visit: creatinine <2.5 x upper limit of normal
9. Adequate hepatic function within 28 days prior to the baseline visit: LFT <1.5 x upper limit of normal, serum amylase <1.5 x upper limit of normal
10. Prothrombin (PT) or INR (International Normalised Ratio) and Prothrombin Time (PTT) < 1.5 x upper limit of normal
11. Able to swallow tablets
12. Patients with the potential for pregnancy or impregnating their partner must agree to use acceptable methods of birth control to avoid conception. Female patients must agree to employ two barrier methods of contraception (e.g. condom, diaphragm with spermicidal jelly) during the trial and for 3 months following the end of their trial participation. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
13. Women of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit.
1. Hypersensitivity to ritonavir or lopinavir or any of its excipients
2. Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4. See current SmPC for details of medications. Participants who have not had their contraindicated medication either discontinued or switched to a different medication at least 2 weeks prior to starting the trial drug.
3. Cardiac arrhythmias requiring anti-arrhythmics (beta-blockers and digoxin are allowed)
4. Symptomatic coronary artery disease or ischemia
5. Myocardial infarction (MI) within the last 6 months; congestive cardiac failure >NYHA Class II
6. Active clinically serious bacterial or fungal infections
7. Known diagnosis of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
8. Prior treatment with Norvir/Kaletra
9. Pregnant or breastfeeding
10. Patients with uncontrolled hypertension
11. Serious uncontrolled concomitant medical or psychiatric illness
12. Grade 3 or higher impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)
13. History of acute pancreatitis within one year of trial entry or medical history of chronic pancreatitis
14. History of another primary malignancy that is currently clinically significant or currently requires active intervention
15. Any other clinically significant medical or surgical condition which, according to the CI/PI’s discretion, should preclude participation
16. History of significant congenital or acquired bleeding disorder
17. Patients taking warfarin or cytotoxic drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method