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

This study has been terminated.
(Due to insufficient funds)
Sponsor:
Collaborators:
Abbott
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Margolis, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00614458
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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Raltegravir; valproic acid

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Effect on Latent HIV of Adding Raltegravir and VPA to ART Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART

Participant Flow:   Overall Study
    Effect on Latent HIV of Adding Raltegravir and VPA to ART  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 8  
Gender  
[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
e-mail: dmargo@med.unc.edu


Publications of Results:

Responsible Party: David Margolis, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00614458     History of Changes
Obsolete Identifiers: NCT00576290
Other Study ID Numbers: 10493, R01AI064074, P30AI050410, U01AI067854
Study First Received: January 31, 2008
Results First Received: April 15, 2011
Last Updated: October 24, 2011
Health Authority: United States: Food and Drug Administration