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

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: NCT00614458
Recruitment Status : Terminated (Due to insufficient funds)
First Posted : February 13, 2008
Results First Posted : October 25, 2011
Last Update Posted : October 25, 2011
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Raltegravir; valproic acid

  Participant Flow

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
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

  Baseline Characteristics

  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

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

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 ( U.S. NIH Grant/Contract )
P30AI050410 ( U.S. NIH Grant/Contract )
U01AI067854 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2008
First Posted: February 13, 2008
Results First Submitted: April 15, 2011
Results First Posted: October 25, 2011
Last Update Posted: October 25, 2011