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Addition of Raltegravir to Established Antiretroviral Suppressive Therapy

This study has been terminated.
(Poor enrollment.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Rafael Campo, University of Miami
ClinicalTrials.gov Identifier:
NCT01245101
First received: November 19, 2010
Last updated: October 28, 2016
Last verified: October 2016
Results First Received: March 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: Raltegravir

  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
Please note: because of poor enrollment and inability to find the originally planned 40 patients, the study was terminated after only 15 of 20 planned patients had been enrolled into the Raltegravir Then Observation arm. No patients were enrolled into the Observation Then Raltegravir arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Raltegravir Then Observation Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
Observation Then Raltegravir Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.

Participant Flow for 3 periods

Period 1:   Period 1 (Treatment)
    Raltegravir Then Observation   Observation Then Raltegravir
STARTED   15   0 
COMPLETED   13   0 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 

Period 2:   Period 2 (Washout)
    Raltegravir Then Observation   Observation Then Raltegravir
STARTED   13   0 
COMPLETED   12   0 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 

Period 3:   Period 3 (Treatment)
    Raltegravir Then Observation   Observation Then Raltegravir
STARTED   12   0 
COMPLETED   11   0 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                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.
No text entered.

Reporting Groups
  Description
Raltegravir Then Observation Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
Observation Then Raltegravir Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
Total Total of all reporting groups

Baseline Measures
   Raltegravir Then Observation   Observation Then Raltegravir   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   0   15 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%         0   0.0% 
Between 18 and 65 years      13  86.7%         13  86.7% 
>=65 years      2  13.3%         2  13.3% 
Gender 
[Units: Participants]
Count of Participants
     
Female      11  73.3%         11  73.3% 
Male      4  26.7%         4  26.7% 


  Outcome Measures
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1.  Primary:   Episomal HIV cDNA Formation   [ Time Frame: 16 weeks ]

2.  Secondary:   Markers of Immune Activation   [ Time Frame: 16 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
Only 11 of 12 patients completed week 40 and were analyzed as per protocol. In view of poor enrollment and a simple analysis of the limited amount of data that failed to support our hypothesis, the study was terminated early.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rafael E. Campo
Organization: University of Miami
phone: 305-689-7030
e-mail: rcampo@med.miami.edu



Responsible Party: Rafael Campo, University of Miami
ClinicalTrials.gov Identifier: NCT01245101     History of Changes
Other Study ID Numbers: 20100499
Study First Received: November 19, 2010
Results First Received: March 24, 2016
Last Updated: October 28, 2016