HIVSPIRIT-XPBNCT07415811
Spironolactone and XPB-1 Integrity in the TFIIH Complex
A study testing Spironolactone (drug) in people with HIV, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Spironolactone (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Jul 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or breastfeeding.
- Known hypersensitivity or contraindication to spironolactone.
- Clinically significant baseline electrolyte abnormalities, including hyperkalemia, or conditions that increase the risk of hyperkalemia.
- Clinically significant renal dysfunction or hepatic dysfunction that, in the investigator's judgment, increases risk with spironolactone.
- History of clinically significant cardiac arrhythmias or screening electrocardiogram findings that contraindicate spironolactone in the investigator's judgment.
- Use of aspirin (acetylsalicylic acid) on a continuous basis or recent use prior to screening, or planned use during the study.
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- 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.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids that cannot be discontinued for the duration of study drug administration.
- Any condition that, in the investigator's judgment, would interfere with study participation, study procedures, or participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Grupo de Pesquisa Clínica em Moléstias Infecciosas
São Paulo, São Paulo, 05401000
About this study
Official title: Evaluation of the Impact of Spironolactone Use on the Integrity of the XPB-1 Subunit of the TFIIH Complex In Vivo
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.
Read more
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.
Read the detailed description
Detailed Description
This study is an exploratory, interventional clinical investigation designed to characterize the biological and pharmacokinetic effects of spironolactone in adult participants, with a particular focus on its ability to induce proteolytic degradation of the XPB (ERCC3) protein and its potential implications for HIV persistence.
Scientific Rationale
The transcription factor IIH (TFIIH) complex plays a central role in RNA polymerase II-mediated transcription initiation and nucleotide excision repair. XPB (ERCC3), an ATP-dependent 3'-5' DNA helicase and a core subunit of TFIIH, is essential for DNA unwinding during transcription and is also required for efficient replication of several viruses, including HIV. Preclinical studies have demonstrated that spironolactone and its active metabolites induce rapid, reversible proteasomal degradation of XPB without causing generalized cytotoxicity or impairing cellular viability.
In models of HIV infection, depletion of XPB has been shown to inhibit Tat-dependent viral transcription, suppress viral replication, and prevent reactivation of latent proviruses in CD4+ T cells. These findings suggest that pharmacological targeting of XPB may represent a novel host-directed strategy to suppress HIV transcription and stabilize viral latency, consistent with a "block-and-lock" approach to HIV cure research. However, the clinical reproducibility of XPB degradation and its relationship with systemic drug exposure in humans remain insufficiently characterized.
Study Design
Participants will receive oral spironolactone administered once daily using a stepwise dose-escalation strategy based on individual tolerability. The intervention period will be followed by a post-treatment observation phase to assess reversibility of biological effects and safety parameters. Dose adjustments, temporary interruptions, or discontinuation of the study drug will be permitted according to predefined safety criteria.
The study includes both HIV-negative individuals and people living with HIV receiving suppressive antiretroviral therapy with sustained plasma viral suppression. This design allows evaluation of XPB degradation in the absence of viral infection as well as assessment of downstream effects on viral persistence in individuals living with HIV.
Pharmacokinetic and Pharmacodynamic Assessments
Systemic exposure to spironolactone and its major metabolites, including canrenone and thiomethylated derivatives, will be quantified using validated liquid chromatography-tandem mass spectrometry methods. Pharmacokinetic parameters will be derived to characterize drug absorption, metabolism, and elimination during dose escalation and steady-state conditions.
Pharmacodynamic effects will be assessed by measuring XPB protein levels in isolated CD4+ T cells obtained from peripheral blood samples. XPB degradation profiles will be correlated with circulating concentrations of spironolactone and its metabolites to explore exposure-response relationships.
Evaluation of HIV Reservoir
In participants living with HIV, the impact of spironolactone exposure on viral persistence will be evaluated using complementary molecular and functional assays. These include quantification of cell-associated HIV DNA and RNA as markers of infected cell frequency and transcriptional activity, as well as functional assessment of replication-competent virus using viral outgrowth methodologies. These analyses aim to determine whether XPB degradation is associated with modulation of the size or transcriptional activity of the latent HIV reservoir.
Safety Monitoring
Safety assessments will include regular clinical evaluations, vital signs, laboratory testing with particular attention to electrolyte balance, renal and hepatic function, and electrocardiographic monitoring. Adverse events will be graded and managed according to predefined criteria, and participant safety will be continuously reviewed throughout the study.
Exploratory Objectives
Exploratory analyses will examine relationships between drug exposure, XPB degradation, and virological parameters, as well as the reversibility of observed biological effects following treatment discontinuation. The results of this study are intended to inform the design of subsequent clinical investigations evaluating spironolactone or related compounds as host-directed agents within HIV cure strategies.
- Conditions
- HIV
- Being tested
- Spironolactone (drug)
- Keywords
- HIV, Spironolactone, HIV Cure, XPB, Block and Lock
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone (drug)Drug
Also called Aldactone®
Oral spironolactone starting at 50 mg once daily with weekly 50 mg increments up to 400 mg/day as tolerated; dosing schedule per protocol.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV (PLWH) | Experimental | Participants with HIV on suppressive ART will receive oral spironolactone dose escalation. Receives: Drug: Spironolactone (drug) |
| People without HIV (HIV-negative) | Experimental | HIV-negative participants will receive the same oral spironolactone dose escalation. Receives: Drug: Spironolactone (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
XPB Protein Degradation in CD4+ T Cells
Change in XPB (ERCC3) protein levels in peripheral blood CD4+ T cells following oral administration of spironolactone, assessed by immunoblotting and expressed as relative protein abundance compared with baseline.
Measured: Baseline through up to 4 weeks of spironolactone treatment.
Secondary outcomes (8)
Peak Plasma Concentration (Cmax) of Spironolactone and Canrenone
Maximum observed plasma concentration (Cmax) of spironolactone and its major active metabolite canrenone, measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Measured: Baseline to Week 4 of spironolactone treatment.
Area Under the Plasma Concentration-Time Curve (AUC) of Spironolactone and Canrenone
Area under the plasma concentration-time curve (AUC) of spironolactone and its major active metabolite canrenone, determined using LC-MS/MS.
Measured: Baseline to Week 4 of spironolactone treatment.
Elimination Half-Life (t½) of Spironolactone and Canrenone
Terminal elimination half-life (t½) of spironolactone and its major active metabolite canrenone, calculated from plasma concentration-time data obtained by LC-MS/MS.
Measured: Baseline to Week 4 of spironolactone treatment.
Correlation Between Spironolactone/Canrenone Plasma Concentrations and XPB (ERCC3) Protein Degradation
Association between plasma concentrations of spironolactone and canrenone (ng/mL, measured by LC-MS/MS) and XPB (ERCC3) protein abundance in peripheral blood CD4+ T cells (relative abundance vs baseline, assessed by immunoblotting/Western blot).
Measured: Baseline to Week 4 of spironolactone treatment.
Cell-Associated HIV-1 DNA Levels in CD4+ T Cells
Change in cell-associated HIV-1 DNA levels in peripheral blood CD4+ T cells, quantified by digital droplet PCR (ddPCR) and expressed as copies per 10⁶ CD4+ T cells, as a measure of the frequency of infected cells in participants living with HIV.
Measured: Baseline to Week 4 of spironolactone treatment.
Cell-Associated HIV-1 RNA Levels in CD4+ T Cells
Change in cell-associated HIV-1 RNA levels in peripheral blood CD4+ T cells, quantified by digital droplet PCR (ddPCR) and expressed as copies per 10⁶ CD4+ T cells, as a measure of HIV transcriptional activity in participants living with HIV.
Measured: Baseline to Week 4 of spironolactone treatment.
Replication-Competent HIV Reservoir (QVOA)
Change in the frequency of replication-competent HIV in peripheral blood CD4+ T cells from participants living with HIV, measured by quantitative viral outgrowth assay (QVOA) and expressed as infectious units per million CD4+ T cells (IUPM).
Measured: Baseline to Week 4 of spironolactone treatment.
Safety and Tolerability of Spironolactone
Incidence, severity, and relationship to study drug of adverse events, laboratory abnormalities (including serum potassium and renal function), and clinically significant changes in vital signs and electrocardiographic parameters during spironolactone treatment and post-treatment follow-up.
Measured: Baseline through study completion (up to 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 Jul 2024
- Primary completion11 Dec 2024
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scripps Research Institute
- Responsible party
- Principal investigator, Ferdinando Lima de Menezes, University of Sao Paulo General Hospital
- Investigators
- Esper G. Kallas, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415811
- Sponsor's protocol ID
- 61791622.6.0000.0068
- Acronym
- SPIRIT-XPB
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual laboratory results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Spironolactone Use on the Integrity of the XPB-1 Subunit of the TFIIH Complex In Vivo
- ClinicalTrials.gov ID
- NCT07415811
- Acronym / sponsor ID
- SPIRIT-XPB / 61791622.6.0000.0068
- Conditions
- HIV
- Keywords
- HIV, Spironolactone, HIV Cure, XPB, Block and Lock
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- The Scripps Research Institute
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
This study is an exploratory, interventional clinical investigation designed to characterize the biological and pharmacokinetic effects of spironolactone in adult participants, with a particular focus on its ability to induce proteolytic degradation of the XPB (ERCC3) protein and its potential implications for HIV persistence.
Scientific Rationale
The transcription factor IIH (TFIIH) complex plays a central role in RNA polymerase II-mediated transcription initiation and nucleotide excision repair. XPB (ERCC3), an ATP-dependent 3'-5' DNA helicase and a core subunit of TFIIH, is essential for DNA unwinding during transcription and is also required for efficient replication of several viruses, including HIV. Preclinical studies have demonstrated that spironolactone and its active metabolites induce rapid, reversible proteasomal degradation of XPB without causing generalized cytotoxicity or impairing cellular viability.
In models of HIV infection, depletion of XPB has been shown to inhibit Tat-dependent viral transcription, suppress viral replication, and prevent reactivation of latent proviruses in CD4+ T cells. These findings suggest that pharmacological targeting of XPB may represent a novel host-directed strategy to suppress HIV transcription and stabilize viral latency, consistent with a "block-and-lock" approach to HIV cure research. However, the clinical reproducibility of XPB degradation and its relationship with systemic drug exposure in humans remain insufficiently characterized.
Study Design
Participants will receive oral spironolactone administered once daily using a stepwise dose-escalation strategy based on individual tolerability. The intervention period will be followed by a post-treatment observation phase to assess reversibility of biological effects and safety parameters. Dose adjustments, temporary interruptions, or discontinuation of the study drug will be permitted according to predefined safety criteria.
The study includes both HIV-negative individuals and people living with HIV receiving suppressive antiretroviral therapy with sustained plasma viral suppression. This design allows evaluation of XPB degradation in the absence of viral infection as well as assessment of downstream effects on viral persistence in individuals living with HIV.
Pharmacokinetic and Pharmacodynamic Assessments
Systemic exposure to spironolactone and its major metabolites, including canrenone and thiomethylated derivatives, will be quantified using validated liquid chromatography-tandem mass spectrometry methods. Pharmacokinetic parameters will be derived to characterize drug absorption, metabolism, and elimination during dose escalation and steady-state conditions.
Pharmacodynamic effects will be assessed by measuring XPB protein levels in isolated CD4+ T cells obtained from peripheral blood samples. XPB degradation profiles will be correlated with circulating concentrations of spironolactone and its metabolites to explore exposure-response relationships.
Evaluation of HIV Reservoir
In participants living with HIV, the impact of spironolactone exposure on viral persistence will be evaluated using complementary molecular and functional assays. These include quantification of cell-associated HIV DNA and RNA as markers of infected cell frequency and transcriptional activity, as well as functional assessment of replication-competent virus using viral outgrowth methodologies. These analyses aim to determine whether XPB degradation is associated with modulation of the size or transcriptional activity of the latent HIV reservoir.
Safety Monitoring
Safety assessments will include regular clinical evaluations, vital signs, laboratory testing with particular attention to electrolyte balance, renal and hepatic function, and electrocardiographic monitoring. Adverse events will be graded and managed according to predefined criteria, and participant safety will be continuously reviewed throughout the study.
Exploratory Objectives
Exploratory analyses will examine relationships between drug exposure, XPB degradation, and virological parameters, as well as the reversibility of observed biological effects following treatment discontinuation. The results of this study are intended to inform the design of subsequent clinical investigations evaluating spironolactone or related compounds as host-directed agents within HIV cure strategies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with HIV (PLWH) | Experimental | Drug: Spironolactone (drug)Participants with HIV on suppressive ART will receive oral spironolactone dose escalation. |
| People without HIV (HIV-negative) | Experimental | Drug: Spironolactone (drug)HIV-negative participants will receive the same oral spironolactone dose escalation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding.
- Known hypersensitivity or contraindication to spironolactone.
- Clinically significant baseline electrolyte abnormalities, including hyperkalemia, or conditions that increase the risk of hyperkalemia.
- Clinically significant renal dysfunction or hepatic dysfunction that, in the investigator's judgment, increases risk with spironolactone.
- History of clinically significant cardiac arrhythmias or screening electrocardiogram findings that contraindicate spironolactone in the investigator's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone (drug)Also: Aldactone®Oral spironolactone starting at 50 mg once daily with weekly 50 mg increments up to 400 mg/day as tolerated; dosing schedule per protocol. | Drug | People living with HIV (PLWH), People without HIV (HIV-negative) |
Primary outcome
XPB Protein Degradation in CD4+ T Cells
Time frame: Baseline through up to 4 weeks of spironolactone treatment.
Change in XPB (ERCC3) protein levels in peripheral blood CD4+ T cells following oral administration of spironolactone, assessed by immunoblotting and expressed as relative protein abundance compared with baseline.
8 secondary outcomes
Peak Plasma Concentration (Cmax) of Spironolactone and Canrenone
Time frame: Baseline to Week 4 of spironolactone treatment.
Area Under the Plasma Concentration-Time Curve (AUC) of Spironolactone and Canrenone
Time frame: Baseline to Week 4 of spironolactone treatment.
Elimination Half-Life (t½) of Spironolactone and Canrenone
Time frame: Baseline to Week 4 of spironolactone treatment.
Correlation Between Spironolactone/Canrenone Plasma Concentrations and XPB (ERCC3) Protein Degradation
Time frame: Baseline to Week 4 of spironolactone treatment.
Cell-Associated HIV-1 DNA Levels in CD4+ T Cells
Time frame: Baseline to Week 4 of spironolactone treatment.
Cell-Associated HIV-1 RNA Levels in CD4+ T Cells
Time frame: Baseline to Week 4 of spironolactone treatment.
Replication-Competent HIV Reservoir (QVOA)
Time frame: Baseline to Week 4 of spironolactone treatment.
Safety and Tolerability of Spironolactone
Time frame: Baseline through study completion (up to 8 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual laboratory results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esper G. Kallas, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spironolactone (drug) in people with HIV, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
XPB Protein Degradation in CD4+ T Cells (time frame: Baseline through up to 4 weeks of spironolactone treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.