A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV (HANDral)

This study has been terminated.
(Funding withdrawn based on unacceptably slow recruitment rate.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bruce Brew, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier:
NCT01448486
First received: October 5, 2011
Last updated: November 13, 2013
Last verified: November 2013
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Human Immunodeficiency Virus (HIV)
HIV Associated Neurocognitive Disorders (HAND)
Intervention: Drug: Raltegravir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period from October 2011 to October 2013. Participants were known patients of the PI or referred from local tertiary sexual health clinics by associate investigators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
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).

Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.

Standard of Care HAART Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).

Participant Flow:   Overall Study
    Raltegravir     Standard of Care HAART  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.

Standard of Care HAART Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
Total Total of all reporting groups

Baseline Measures
    Raltegravir     Standard of Care HAART     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     3     6  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52.0  ± 8.7     59.3  ± 4.9     55.7  ± 7.5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     3     3     6  



  Outcome Measures
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1.  Primary:   Neurocognitive Function   [ Time Frame: Change from baseline neuropsychological testing, at 6 months, and at 12 months ]

2.  Secondary:   Cerebrospinal Fluid   [ Time Frame: Change in Neopterin concentrations in CSF from baseline to 12 months ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
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).

Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.

Standard of Care HAART Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).

Serious Adverse Events
    Raltegravir     Standard of Care HAART  
Total, serious adverse events      
# participants affected / at risk     0/3 (0.00%)     0/3 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to incomplete dataset with sample size too small to produce any meaningful statistical analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Bruce Brew
Organization: St. Vincent's Hospital, Sydney
phone: 61 2 8382 1111 ext 4100
e-mail: b.brew@unsw.edu.au


No publications provided


Responsible Party: Bruce Brew, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT01448486     History of Changes
Other Study ID Numbers: 11/033, IISP 37693
Study First Received: October 5, 2011
Results First Received: November 13, 2013
Last Updated: November 13, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration