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Chronic HIV InfectionsPhase 2/3NCT02902185

Chidamide in Combination With ART for Reactivation of the Latent HIV-1 Reservoir

A Phase 2/3 study testing ART plus Chidamide in people with Chronic HIV Infections, run by Tang-Du Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS) can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected people must remain on treatment continuously to avoid viral rebound and progression to AIDS. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic HIV Infections
What is being tested?
ART plus Chidamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
3 sitesChina
Study dates
29 Nov 2016to Dec 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented HIV-1 infection
  • Currently receiving cART and having received cART for a minimum of 24 months, HIV-1 plasma RNA <20 copies/mL for at least 1.5 year (excluding viral load blips)
  • CD4 T cell count >350 cells/mm3
  • Able, willing to give written informed consent and to adhere to therapy and to comply with time requirements for study visits and evaluations
  • Adequate vascular access for leukapheresis

Who cannot join

  • Acute HIV-1 infection
  • Received blood transfusions or hematopoetic growth factors within 3 months receipt of compounds with HDAC inhibitor-like activity, such as valproic acid within the last 1 month. Potential participants may enroll after a 30-day washout period.
  • Any significant acute medical illness in the past 8 weeks
  • Any evidence of an active AIDS-defining opportunistic infection
  • Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
  • Patient has the following laboratory values within 3 weeks before starting the investigational drug
Show all 19Show fewer
  • Hepatic transaminases (AST or ALT) ≥3 x upper limit of normal (ULN)
  • Serum total bilirubin ≥1.5 ULN
  • Serum creatinine levels ≥1.5 x ULN, or calculated creatinine clearance ≤60 ml/min
  • Platelet count ≤100 x109/L
  • Absolute neutrophil count ≤1.5x109/L
  • Serum potassium, magnesium, phosphorus outside normal limits
  • Total calcium (corrected for serum albumin) or ionized calcium ≤lower normal limits
  • A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for Torsades de pointes (e.g. heart failure)
  • History of malignancy or transplantation, including skin cancers or Kaposi sarcoma
  • History of diabetes mellitus
  • Known hypersensitivity to the components of chidamide or its analogues
  • Pregnancy or breast feeding, or expecting to father children within the projected duration of the study
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Zhejiang University

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University

    Xi'an, Shaanxi, 710038

Other trials in China

About this study

Official title: Efficacy of the Histone Deacetylase Inhibitor Chidamide in Combination With Antiretroviral Therapy for Reactivation of the Latent HIV-1 Reservoir:a Randomized Controlled Clinical Trial

HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS) can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected people must remain on treatment continuously to avoid viral rebound and progression to AIDS. HIV persistence is thought to stem primarily from the presence of integrated copies of the proviral genome within long-lived cells. Because active viral gene expression causes cell death due to viral cytopathic effects and the immune response, long-lived cells likely harbor transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular reservoirs remains a major barrier to a cure. HDACi have the potential to activate ("Kick") these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate ("Kill") the infected cells. This study is subsequent to our NCT02513901. The purpose of this study is to verify the efficacy of multi-dose Chidamide in combination with antiretroviral therapy in HIV-infected adults with suppressed viral load in a randomized controlled clinical trial.

Read the detailed description

Sixty participants will be recruited and stratified by their CD4 cell count(30 for <500 cells/μL and 30 for ≥500 cells/μL). Each layer was 1:1 randomly divided into Chidamide group or Placebo-controlled group.Chidamide and Placebo will be administrated 10mg each time, twice a week, interval not less than 3 days. Chidamide and Placebo intervention will last 12 consecutive weeks. All participants will keep their antiretroviral therapy during this study.

This study will last for 96 weeks, involving 16 study visits(Screening, Week 0, 2, 4, 8, 12, 14, 16, 20, 24, 36, 48, 60, 72, 84, 96) for every participant. At the screening visit, participants will give a medical history and will undergo a physical exam; blood samples will be collected. If participants agree, their blood samples may be stored for future research.

Being tested
ART plus Chidamide, ART plus Placebo
Keywords
Chidamide, Histone Deacetylase Inhibitor, HIV-1 Reservoir, Chronic HIV infections, HIV Eradication, Antiretroviral Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ART plus ChidamideDrug

    Chidamide will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.Antiretroviral therapy will be kept during entire study.

  • ART plus PlaceboDrug

    Placebo will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.Antiretroviral therapy will be kept during entire study.

Study groups in NCT02902185
Study groupRoleWhat they receive
ChidamideExperimentalChidamide will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.
Receives: Drug: ART plus Chidamide
Placebo-controlledPlacebo comparatorPlacebo with the same taste and appearance like Chidamide will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.
Receives: Drug: ART plus Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HIV transcription measured as cell associated HIV-1 RNA (copies per 10E6 PBMCs)

    Measured: Measured on week 0, 2, 4, 8, 12, 14, 16, 24

  2. Change in HIV production measured as plasma HIV RNA (by Roche COMBAS TaqMan HIV-1 Test version 2.0)

    Measured: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96

  3. Change in HIV-1 reservoir size measured in PBMCs by Total HIV-1 DNA(copies per 10E6 PBMCs)

    Measured: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96

Secondary outcomes (3)

  1. Safety and tolerability evaluation as measured by adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR), serious unexpected adverse reactions (SUSAR)

    Measured: Measured through 96 weeks

  2. Cell surface markers of immune activation and immune checkpoints and so on

    Measured: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96

  3. Plasma inflammatory biomarkers

    Measured: Measured on week 0, 4, 8, 12, 16, 24, 48, 72, 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2016 (estimated)
  2. Study start29 Nov 2016
  3. Primary completionAug 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902185
Sponsor's protocol ID
2016TD-Chidamide RCT
Status last verified
Apr 2018
First submitted
6 Sep 2016
Last updated
26 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not have data share plan because of participants' privacy.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ART plus Chidamide in people with Chronic HIV Infections, run by Tang-Du Hospital at 3 sites in China.

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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Change in HIV transcription measured as cell associated HIV-1 RNA (copies per 10E6 PBMCs) (time frame: Measured on week 0, 2, 4, 8, 12, 14, 16, 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02902185.

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 26 Apr 2018.

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