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Trial details imported from ClinicalTrials.gov
Ethics application status
Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy
A Pilot Study to Assess the Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy
Universal Trial Number (UTN)
Acquired immune deficiency syndrome (AIDS / HIV)
Description of intervention(s) / exposure
Treatment: Drugs - Vorinostat
Experimental: Vorinostat - Vorinostat 400mg ( 4 X 100mg ) orally daily for 14 days
Treatment: Drugs: Vorinostat
Vorinostat 400mg (4 x 100mg) orally daily for 14 days
Intervention code 
Comparator / control treatment
Primary outcome 
To evaluate the effect of vorinostat on HIV transcription in CD4 T-cells. - The primary (efficacy) endpoint of this study is to evaluate the effect of vorinostat on HIV transcription from latently infected CD4+ T-cells as measured by HIV unspliced RNA in CD4+ T-cells.
Day 1 (before drug, 2 and 8 hours after first dose), Day 2, 7, 14, 21 and 28
Secondary outcome 
1. To evaluate the safety and tolerability of vorinostat in patients receiving effective combination antiretroviral therapy (cART - Plasma HIV RNA (standard assay)
Adverse events and dose-limiting toxicity
CD4 T-cell count
Antiretroviral plasma trough concentrations will be measured before and after 14 days of treatment with vorinostat.
Screening, Day 1, 7, 14,21, and 28
Key inclusion criteria
1. HIV -1 infected adults
2. HIV-1 plasma RNA <50 copies/ml for at least 3 years with at least 2 viral load
measures per year, and most recent viral load within 3 months of screening. Episodes
of a single HIV plasma RNA 50-199 copies/ml will not exclude participation if the
subsequent HIV plasma RNA was <50 copies/ml.
3. Receiving combination antiretroviral therapy (at least 3 agents)
4. In the last 6 months have two CD4 cell count greater than 500 cell/µl
5. Documented subtype B HIV infection
6. Detectable HIV RNA on stored specimen
7. Able to give informed consent
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Any significant acute medical illness in the past 8 weeks.
2. Any evidence of an active AIDS-defining opportunistic infection.
3. Current or recent gastrointestinal disease that may impact the absorption of study
4. Any gastrointestinal surgery that could impact upon the absorption of study drug.
5. Active alcohol or substance use that, in the Investigator's opinion, will prevent
adequate compliance with study therapy .
6. Moderate to severe hepatic impairment
7. Hepatic transaminases (AST or ALT) > 3 x upper limit of normal (ULN)
8. Hepatitis B infection as indicated by the presence of Hepatitis B surface antigen or
detectable DNA levels in blood.
9. 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).
10. History of malignancy or transplantation, including skin cancers or Kaposi sarcoma
11. History of diabetes mellitus
12. Use of an HIV protease inhibitor.
13. Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents
within 28 days prior to screening.
14. Use of an agent definitely or possibly associated with effects on QT intervals within
2 weeks of screening.
15. Receipt of sodium valproate or other HDAC inhibitor at any time.
16. Women who are pregnant or breastfeeding, or with a positive pregnancy test during
screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to
use an acceptable method of contraception to avoid pregnancy for the entire study
period and for at least 4 weeks before and 4 weeks after the study.
17. Males who are unwilling or unable to use barrier contraception during vaginal
intercourse from the time of enrollment and for 12 weeks after participation in the
study are also excluded.
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
The Alfred Hospital - Infectious Diseases Unit - Melbourne
Recruitment postcode(s) 
Other collaborator category 
Merck Sharp & Dohme Corp.
Ethics application status
The objective of the study is to assess the safety and ability of vorinostat, a drug
currently licensed for the treatment of a type of lymphoma, to 'turn on' dormant HIV infected
Trial related presentations / publications