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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Abbott
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
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Effect on Latent HIV of Adding Raltegravir and VPA to ART
Hide Arm/Group Description 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
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Effect on Latent HIV of Adding Raltegravir and/or VPA to ART
Hide Arm/Group Description 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
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
36  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title A Change in the Number of HIV Infected Cells.
Hide Description A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants analyzed per protocol
Arm/Group Title Effect on Latent HIV of Adding Raltegravir and VPA to ART
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: infected cells /million cells
0.390
(0.03 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Effect on Latent HIV of Adding Raltegravir and/or VPA to ART
Hide Arm/Group Description 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
All-Cause Mortality
Effect on Latent HIV of Adding Raltegravir and/or VPA to ART
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Effect on Latent HIV of Adding Raltegravir and/or VPA to ART
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Effect on Latent HIV of Adding Raltegravir and/or VPA to ART
Affected / at Risk (%)
Total   0/6 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Professor of Medicine, Director Translational Research IGHID
Organization: UNC Chapel Hill
Phone: 919 966 6388
EMail: dmargo@med.unc.edu
Layout table for additonal information
Responsible Party: David Margolis, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00614458    
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