Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology

Who is this study for? Patients with Aicardi-Goutières syndrome
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Aicardi-Goutières syndrome (AGS) is a disease of children, particularly affecting the brain and the skin. There is a close link between AGS and increased amounts of a chemical called interferon. Normally humans only produce interferon when they are infected with a virus. In AGS, there is no viral infection. Instead, the cells in the cells of affected patients are confused into thinking that their own genetic material is coming from a virus. As a result they produce interferon all the time, which acts as a poison that damages the cells. The Investigators wish to treat AGS patients with drugs called reverse transcriptase inhibitors (RTIs), used to fight the HIV-1 virus that causes AIDS. The investigators will monitor the effect of treatment on interferon levels, and look at other markers which might give us clues to how the drugs are working. The trial is funded by the Medical Research Council, and involves experts based in Edinburgh, Birmingham, Manchester and Great Ormond Street Hospital.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 15
Healthy Volunteers: f
View:

• Patients with mutations in any of TREX1, the three components of the RNase H2 complex (RNASEH2A, RNASEH2B, RNASEH2C: considered as one genotype) or SAMHD1.

• Greater than age 3 months and less than 16 years of age at the time of recruitment

• Resident in the United Kingdom (UK)

• Informed Consent obtained from parent or personal legal representative

• For inclusion in the study, a patient has either to have completed the vaccination programme two weeks prior to starting the trial, or remain unvaccinated until the end of the trial, or agree to defer vaccination until immediately after a study drug arm, so that there is a period of at least two weeks following vaccination and before the start of the following drug arm.

Locations
Other Locations
United Kingdom
Yanick Crow
Edinburgh
Time Frame
Start Date: 2022-08-24
Completion Date: 2024-03-11
Participants
Target number of participants: 13
Treatments
Active_comparator: Abacavir (ABC)
Participants receive Abacavir (ABC) for 6 weeks and 4 weeks of washout.
Active_comparator: Lamivudine (3TC)
Participants receive Lamivudine (3TC) for 6 weeks and 4 weeks of washout.
Active_comparator: Abacavir (ABC)+Lamivudine (3TC)+Zidovudine (AZT)
Participants receive Abacavir (ABC)+Lamivudine (3TC)+Zidovudine (AZT) for 6 weeks and 4 weeks of washout.
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Council, NHS Lothian
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.