Chidamide in Combination With ART for Reactivation of the Latent HIV-1 Reservoir
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ClinicalTrials.gov Identifier: NCT02902185 |
Recruitment Status : Unknown
Verified April 2018 by Yongtao Sun, MD, PhD, Tang-Du Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : April 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic HIV Infections | Drug: ART plus Chidamide Drug: ART plus Placebo | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 29, 2016 |
Estimated Primary Completion Date : | August 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
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Experimental: Chidamide
Chidamide will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.
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Drug: ART plus Chidamide
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. |
Placebo Comparator: Placebo-controlled
Placebo 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.
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Drug: ART plus Placebo
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. |
- 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 ]
- Change in HIV production measured as plasma HIV RNA (by Roche COMBAS TaqMan HIV-1 Test version 2.0) [ Time Frame: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96 ]
- Change in HIV-1 reservoir size measured in PBMCs by Total HIV-1 DNA(copies per 10E6 PBMCs) [ Time Frame: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96 ]
- 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) [ Time Frame: Measured through 96 weeks ]
- Cell surface markers of immune activation and immune checkpoints and so on [ Time Frame: Measured on week 0, 2, 4, 8, 12, 14, 16, 24, 36, 48, 60, 72, 84, 96 ]
- Plasma inflammatory biomarkers [ Time Frame: Measured on week 0, 4, 8, 12, 16, 24, 48, 72, 96 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Patient has the following laboratory values within 3 weeks before starting the investigational drug
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902185
China, Guangxi | |
The First Affiliated Hospital of Guangxi Medical University | |
Nanning, Guangxi, China | |
China, Shaanxi | |
Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University | |
Xi'an, Shaanxi, China, 710038 | |
China, Zhejiang | |
Zhejiang University | |
Hangzhou, Zhejiang, China |
Responsible Party: | Yongtao Sun, MD, PhD, Director of Department of Infectious Diseases, Tang-Du Hospital |
ClinicalTrials.gov Identifier: | NCT02902185 |
Other Study ID Numbers: |
2016TD-Chidamide RCT |
First Posted: | September 15, 2016 Key Record Dates |
Last Update Posted: | April 26, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We do not have data share plan because of participants' privacy. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chidamide Histone Deacetylase Inhibitor HIV-1 Reservoir |
Chronic HIV infections HIV Eradication Antiretroviral Therapy |
HIV Infections Infections Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |