Studying Topiramate for Re-Activating the HIV-1 Reservoir

Launched by ERASMUS MEDICAL CENTER · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called topiramate to help find and eliminate the hidden HIV virus in people living with HIV. Even with current treatments, HIV can remain in the body for life because it hides in certain cells. The goal of this trial is to see if topiramate can "wake up" the virus from these cells without harming the healthy cells, allowing for better chances of getting rid of it completely. Researchers want to ensure that both men and women are included in this study, as previous trials mostly involved men, and responses to treatment can differ between genders.

To participate in this trial, you must be at least 18 years old, have documented HIV-1, and have been on antiretroviral therapy (ART) for at least two years. You should also have a low level of the virus in your blood and a healthy immune cell count. Participants will have regular check-ups and will be monitored closely throughout the study. It's important to note that certain health conditions or medications could make someone ineligible to join. This trial aims to contribute to finding a potential cure for HIV that works for everyone.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented HIV-1, subtype B or C
• • Aged 18 or over
• • On ART for a minimum of 2 consecutive years and a maximum of 12 consecutive years
• • HIV-1 RNA plasma level \<30 copies/mL for at least two consecutive measurements prior to inclusion (viral blips with a detectable HIVRNA 30-200 c/mL preceded and followed by HIV-RNA \<30 are allowed)
• • CD4+ T cell count ≥200 cells/mm\^3 at screening
• • Able to understand the information and give informed consent
• Exclusion Criteria:
• • Any major acute medical condition requiring hospitalisation within the past 4 weeks.
• • Presence of an active opportunistic infection that defines Acquired Immunodeficiency Syndrome (AIDS).
• • Any medical condition deemed by the investigator to hinder compliance with the study treatment.
• • The following laboratory values at the screening phase (available before baseline (T0)): hepatic transaminases (AST or ALT) ≥3 times the upper limit of normal (ULN), serum total bilirubin ≥3 times the ULN, estimated glomerular filtration rate (eGFR) ≤60 mL/min based on CKD-EPI, haemoglobin \<6.5 mmol/L (males) or \<6.0 mmol/L (females), leucocytes \<2.5 x10\^9/L, absolute neutrophil count \<1000 cells/mm\^3, thrombocytes \<100 x10\^9/L
• • Active malignancy during the past year except for basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with ART alone, or other indolent malignancies.
• • Participants who are unwilling or unable to use barrier contraception during sexual intercourse during the study.
• • History of suicide or suicidal ideation.
• • History of ophthalmological medical problems leading to glaucoma or visual field disturbances (e.g. macula oedema). Refraction abnormalities that can be corrected by lenses are acceptable.
• • History of any medical condition with a causal relationship with hyperammonemia.
• • Participants using phenytoin, carbamazepine, digoxin, lithium, or valproic acid throughout the trial period.
• • Any concurrent medicine use associated with hyperammonemia (e.g. valproic acid).
• • Participants with active substance abuse.
• • Participants who have registered allergies to the investigational medical product.