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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01365065




Registration number
NCT01365065
Ethics application status
Date submitted
1/06/2011
Date registered
3/06/2011
Date last updated
25/04/2017

Titles & IDs
Public title
Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy
Scientific title
A Pilot Study to Assess the Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy
Secondary ID [1] 0 0
U1111-1121-9077
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Positive 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 (before drug, 2 and 8 hours after first dose), Day 2, 7, 14, 21 and 28
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Screening, Day 1, 7, 14,21, and 28

Eligibility
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
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
drug.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Infectious Diseases Unit - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
CD4 T-cells.
Trial website
https://clinicaltrials.gov/show/NCT01365065
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01365065