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Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frank Maldarelli, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00618371
First received: September 29, 2007
Last updated: October 11, 2016
Last verified: October 2016
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV Infection
Intervention: Drug: Raltegravir (MK-0518)

  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
The study was approved in 10/2007. HIV-infected individuals 18 years of age receiving stable, suppressive antiretroviral therapy (ART) with persistent plasma HIV-1 RNA level of > 0.6 copies/mL by single-copy assay at screening; enrollment started in in 12/2007 at the University of Pittsburgh Clinical Trials Unit from 12/2007 through 1/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had Cluster of Differentiation 4(CD4) counts of greater than 200 cells/microliter, HIVRNA< 50 copies/mL plasma for ≥12 months; and not receiving prophylaxis for opportunistic infections (OI)s; no history of exposure to raltegravir, HIV-1 drug resistance,febrile illness within 3 weeks or vaccination within 6 weeks before enrollment.

Reporting Groups
  Description
Group 1 group to be treated with raltegravir

Participant Flow:   Overall Study
    Group 1
STARTED   12 
COMPLETED   10 
NOT COMPLETED   2 
Withdrawal by Subject                2 



  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.
No text entered.

Reporting Groups
  Description
Group 1 Group receiving raltegravir

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   1 
Age 
[Units: Years]
Median (Standard Deviation)
 45.5  (10.6) 
Gender 
[Units: Participants]
 
Female   1 
Male   11 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load   [ Time Frame: 4 weeks ]

2.  Secondary:   Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   09/2018   Safety Issue:   No


  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: Deborah McMahon
Organization: University of Pittsburgh
phone: 412-383-1675
e-mail: mcmahond@pitt.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Frank Maldarelli, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00618371     History of Changes
Other Study ID Numbers: 27XS050
HHSN261200800001E ( Other Grant/Funding Number: SAIC )
ZIABC011464 ( US NIH Grant/Contract Award Number )
Study First Received: September 29, 2007
Results First Received: September 12, 2011
Last Updated: October 11, 2016
Health Authority: United States: Food and Drug Administration