NCT07415811Enrolling by invitation
Spironolactone and XPB-1 Integrity in the TFIIH Complex
Evaluation of the Impact of Spironolactone Use on the Integrity of the XPB-1 Subunit of the TFIIH Complex In Vivo
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
This is a prospective, interventional, exploratory clinical study designed to evaluate the pharmacokinetics, safety, and biological effects of spironolactone on the degradation of the XPB (ERCC3) protein and its potential impact on the HIV reservoir. Spironolactone is an FDA-approved mineralocorticoid receptor antagonist that has recently been shown in preclinical studies to induce rapid and reversible proteolytic degradation of XPB, a key subunit of the transcription factor IIH (TFIIH) complex, which is essential for cellular transcription, DNA repair, and viral replication. The study will enroll adult participants, including both HIV-negative individuals and people living with HIV receiving suppressive antiretroviral therapy with undetectable plasma viral load. Participants will receive oral spironolactone with stepwise dose escalation according to individual tolerability, followed by a post-treatment follow-up period. Primary assessments include evaluation of XPB protein degradation in CD4+ T cells and characterization of the pharmacokinetic profile of spironolactone and its active metabolites. In participants living with HIV, secondary assessments include quantitative and functional measurements of the HIV reservoir. Safety will be monitored throughout the study through clinical evaluations, laboratory testing, and electrocardiographic assessments. This study aims to generate initial clinical evidence supporting the repositioning of spironolactone as a potential component of HIV cure strategies, particularly within a "block-and-lock" approach targeting sustained viral transcriptional silencing.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 25 Jan 2026
- Start date
- 24 Jul 2024
- Primary completion date
- 11 Dec 2024
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- HIV
- NCT number
- NCT07415811
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 24 Jul 2024 to the primary completion date, 11 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of aspirin (acetylsalicylic acid) on a continuous basis or recent use prior to screening, or planned use during the study.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids that cannot be discontinued for the duration of study drug administration.
Other illness
- Known hypersensitivity or contraindication to spironolactone.
- Clinically significant baseline electrolyte abnormalities, including hyperkalemia, or conditions that increase the risk of hyperkalemia.
- History of clinically significant cardiac arrhythmias or screening electrocardiogram findings that contraindicate spironolactone in the investigator's judgment.
- Any condition that, in the investigator's judgment, would interfere with study participation, study procedures, or participant safety.
Lab values
- Current use of medications or supplements that increase potassium levels or otherwise substantially increase the risk of hyperkalemia, or inability/unwillingness to avoid high-potassium supplements and products during the intervention period.
Other
- Pregnancy or breastfeeding.
- Clinically significant renal dysfunction or hepatic dysfunction that, in the investigator's judgment, increases risk with spironolactone.
Who the study is looking for
- Adults aged 18 to 60 years.
- Able and willing to provide written informed consent.
- For HIV-negative cohort: documented HIV-negative test result at screening.
- For HIV-positive cohort:
- documented HIV-1 infection;
- on stable antiretroviral therapy (ART); .plasma HIV-1 RNA below the limit of detection at screening.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grupo de Pesquisa Clínica em Moléstias Infecciosas Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.