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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448486
Recruitment Status : Terminated (Funding withdrawn based on unacceptably slow recruitment rate.)
First Posted : October 7, 2011
Results First Posted : January 3, 2014
Last Update Posted : June 27, 2016
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bruce Brew, St Vincent's Hospital, Sydney

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Human Immunodeficiency Virus (HIV)
HIV Associated Neurocognitive Disorders (HAND)
Intervention: Drug: Raltegravir

  Participant Flow

  Baseline Characteristics

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.
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Reporting Groups

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 
Overall Participants Analyzed 
[Units: Participants]
 3   3   6 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   3   3   6 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 52.0  (8.7)   59.3  (4.9)   55.7  (7.5) 
[Units: Participants]
Female   0   0   0 
Male   3   3   6 

  Outcome Measures

1.  Primary:   Neurocognitive Function   [ Time Frame: Baseline, 6 months and 12 months ]

2.  Secondary:   Cerebrospinal Fluid   [ Time Frame: Baseline and 12 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Responsible Party: Bruce Brew, St Vincent's Hospital, Sydney Identifier: NCT01448486     History of Changes
Other Study ID Numbers: 11/033
IISP 37693 ( Other Grant/Funding Number: Merck Sharp & Dohme )
First Submitted: October 5, 2011
First Posted: October 7, 2011
Results First Submitted: November 13, 2013
Results First Posted: January 3, 2014
Last Update Posted: June 27, 2016