A phase II clinical trial investigating the effect of topiramate on the reactivation of the HIV-1 reservoir in people living with HIV on antiretroviral therapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511532-27-00

Enrollment

Registered

2024-06-17

Start date

2024-07-07

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

human immunodeficiency virus 1 (HIV-1)

Brief summary

1. The fold change in cell-associated (CA) HIV-1 RNA after topiramate treatment (T2 (6h), T3 (24h)) compared to baseline (T0). 2. The frequency and severity of adverse events after topiramate treatment.

Detailed description

1. The change in CA HIV-1 RNA compared between arms. 2. Plasma concentrations of topiramate compared between arms. 3. The frequency and severity of adverse events compared between arms. 4. The change in reservoir size after topiramate treatment compared to baseline. 5. The plasma concentration of topiramate compared to CA HIV-1 RNA.

Interventions

DRUGTOPIRAMATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. The fold change in cell-associated (CA) HIV-1 RNA after topiramate treatment (T2 (6h), T3 (24h)) compared to baseline (T0). 2. The frequency and severity of adverse events after topiramate treatment.	—

Secondary

Measure	Time frame
1. The change in CA HIV-1 RNA compared between arms. 2. Plasma concentrations of topiramate compared between arms. 3. The frequency and severity of adverse events compared between arms. 4. The change in reservoir size after topiramate treatment compared to baseline. 5. The plasma concentration of topiramate compared to CA HIV-1 RNA.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026