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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01448486




Registration number
NCT01448486
Ethics application status
Date submitted
5/10/2011
Date registered
7/10/2011
Date last updated
27/06/2016

Titles & IDs
Public title
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV
Scientific title
A Randomised Controlled Clinical Trial of the Efficacy of HAART Intensification With Raltegravir in HIV Virally Suppressed Patients With Cognitive Impairment
Secondary ID [1] 0 0
IISP 37693
Secondary ID [2] 0 0
11/033
Universal Trial Number (UTN)
Trial acronym
HANDral
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 0 0
HIV Associated Neurocognitive Disorders (HAND) 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Raltegravir

No intervention: Standard of Care HAART - Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).

Experimental: Raltegravir - Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).


Treatment: Drugs: Raltegravir
Oral raltegravir, 400 mg tablet, twice daily for one year.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neurocognitive Function
Timepoint [1] 0 0
Baseline, 6 months and 12 months
Secondary outcome [1] 0 0
Cerebrospinal Fluid
Timepoint [1] 0 0
Baseline and 12 months

Eligibility
Key inclusion criteria
* HIV positive
* On HAART, with plasma HIV viral load < 50 copies/ml for previous 12 months or more
* Able to provide informed consent
* HAND diagnosis, with symptom progression within previous 6 months (while on existing HAART regimen)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-HIV related neurological disorders and active CNS opportunistic infection (as assessed by full blood count, electrolytes, creatinine, glucose, LFT's, cryptococcal antigen, VDRL, MRI brain scan and CSF fluid analysis for cell count, protein, glucose, culture, VDRL and cryptococcal antigen)
* Psychiatric disorders on the psychotic axis
* Current major depression
* Current substance use disorder, or severe substance use disorders within 12 months of study entry
* Active HCV (detectable HCV RNA)
* History of loss of consciousness > 1 hour
* Non-proficient in English
* Medications known to pharmacologically interact with ARV's
* Currently taking an Integrase Inhibitor
* Pregnancy (as assessed by the urine pregnancy test)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital, Sydney
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bruce J Brew, MBBS, PhD
Address 0 0
St Vincent's Hospital, Sydney
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

No information has been provided regarding IPD availability


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 are available at https://clinicaltrials.gov/study/NCT01448486