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MK-0518 Intensification And HDAC Inhibition In Depletion Of Resting CD4+ T Cell HIV Infection

This study has been terminated.
(Due to insufficient funds)
National Institute of Allergy and Infectious Diseases (NIAID)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Margolis, MD, University of North Carolina, Chapel Hill Identifier:
First received: January 31, 2008
Last updated: October 24, 2011
Last verified: September 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Raltegravir; valproic acid

  Participant Flow

  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.
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Reporting Groups
Effect on Latent HIV of Adding Raltegravir and/or VPA to ART Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART

Baseline Measures
   Effect on Latent HIV of Adding Raltegravir and/or VPA to ART 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 36  (8) 
[Units: Participants]
Female   0 
Male   6 
Region of Enrollment 
[Units: Participants]
United States   6 

  Outcome Measures

1.  Primary:   A Change in the Number of HIV Infected Cells.   [ Time Frame: 20 weeks ]

  Serious Adverse Events

  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
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  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: Professor of Medicine, Director Translational Research IGHID
Organization: UNC Chapel Hill
phone: 919 966 6388

Publications of Results:

Responsible Party: David Margolis, MD, University of North Carolina, Chapel Hill Identifier: NCT00614458     History of Changes
Obsolete Identifiers: NCT00576290
Other Study ID Numbers: 10493
R01AI064074 ( US NIH Grant/Contract Award Number )
P30AI050410 ( US NIH Grant/Contract Award Number )
U01AI067854 ( US NIH Grant/Contract Award Number )
Study First Received: January 31, 2008
Results First Received: April 15, 2011
Last Updated: October 24, 2011