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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02500446




Registration number
NCT02500446
Ethics application status
Date submitted
30/06/2015
Date registered
16/07/2015

Titles & IDs
Public title
Dolutegravir Impact on Residual Replication
Scientific title
Dolutegravir Impact on Residual Replication: Dolutegravir Intensification Study
Secondary ID [1] 0 0
DIORR_20150306
Universal Trial Number (UTN)
Trial acronym
DIORR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dolutegravir
Other interventions - Placebo

Active comparator: Intensification - Oral dolutegravir 50 mg once daily for 8 weeks added to their current ART regimen.

Placebo comparator: Placebo - Oral placebo once daily for 8 weeks added to their current ART regimen.


Treatment: Drugs: dolutegravir
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.

Other interventions: Placebo
A film-coated tablet identical in appearance to the active drug tablet but not containing any dolutegravir or any other active ingredient
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Level of residual HIV replication in circulating CD4+ T cells
Timepoint [1] 0 0
day 7 of treatment
Secondary outcome [1] 0 0
Level of Human Leukocyte Antigen D-related (HLA-DR)
Timepoint [1] 0 0
time points to day 84 (28 days after treatment)
Secondary outcome [2] 0 0
Level of Programmed cell death-1 receptor (PD-1)
Timepoint [2] 0 0
time points to day 84 (28 days after treatment)
Secondary outcome [3] 0 0
Level of Cluster of Differentiation 38 (CD-38)
Timepoint [3] 0 0
time points to day 84 (28 days after treatment)
Secondary outcome [4] 0 0
Level of residual HIV replication in circulating CD4+ T cells in a protease inhibitor -containing regimen
Timepoint [4] 0 0
time points up to day 84 (28 days after treatment)

Eligibility
Key inclusion criteria
* Documented HIV-1 infection
* Minimum age 18 years
* Receiving combination ART (at least 3 agents) for at least 3 years. Twenty of the 40 study participants will be on a PI-based ART regimen.
* HIV-1 plasma RNA <50 copies/mL for >3 years and <20 copies/mL at screening.
* Two CD4+ T cell counts >350 cells/µL in the 24 months prior to screening
* Able to give informed consent
* A female, may be eligible to enter and participate in the study if she:

* Is of non-child-bearing potential OR
* Is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the study protocol-specified methods of contraception to avoid pregnancy:
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known hypersensitivity to DTG or to any of the excipients
* Current use of dofetilide, pilsicainide or metformin
* Current use of etravirine except when etravirine is co-administered with atazanavir/ritonavir, lopinavir/ritonavir or darunavir/ritonavir
* Current or prior use of any integrase inhibitor
* Previous use of histone deacetylase inhibitors or other latency reversing agents
* Any significant acute medical illness requiring hospitalization within preceding 8 weeks
* Significant renal disease (eGFR <50 milliliters per min)
* Hepatitis C co-infection (Individuals with prior hepatitis C infection that is now cleared are eligible for enrolment)
* Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Receipt of immunomodulating agents (excluding immunization) or systemic chemotherapeutic agents within 28 days prior to study entry
* Patients who intend to modify their ART regimen within the study period
* Current or recent gastrointestinal disease or surgery that may impact the absorption of the investigational drug
* Active alcohol or substance use that in the opinion of the investigator will prevent adequate compliance with study procedures
* Currently pregnant, breastfeeding or unwilling to use barrier contraception
* Women of Child Bearing Potential (WOCBP) unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria
* Unable or unwilling to adhere to protocol procedures
* The following laboratory values within 3 weeks before starting the investigational drug (lab tests may be repeated to obtain acceptable values before failure at screening is concluded)

* Hepatic transaminases (AST or ALT) =3 x upper limit of normal (ULN)
* Serum total bilirubin =1.5 x ULN
* eGFR <50 mL/min
* Haemoglobin <11.0 g/dL

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [2] 0 0
Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3010 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
ViiV Healthcare
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Lewin
Address 0 0
Doherty Institute for Immunity and Infection
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan to share individual participant data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02500446