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Effects of Intensive cART During Acute/Early HIV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154673
First Posted: July 1, 2010
Last Update Posted: April 5, 2016
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.
Collaborators:
St. Michael's Hospital, Toronto
Maple Leaf Medical Clinic
Information provided by (Responsible Party):
Mario Ostrowski, University of Toronto
Results First Submitted: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute HIV Infection
Interventions: Drug: raltegravir
Drug: maraviroc
Drug: emtricitabine 200mg /tenofovir 300mg
Drug: lopinavir 400 mg/ritonavir 100mg

  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
No text entered.

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
Intensive HAART

Patients in this arm will receive the following HAART regimen:

Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks

Placebo Arm Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks

Participant Flow:   Overall Study
    Intensive HAART   Placebo Arm
STARTED   16   16 
COMPLETED   14   16 
NOT COMPLETED   2   0 
Lost to Follow-up                1                0 
moved out of province                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
Intensive HAART

Patients in this arm will receive the following HAART regimen:

Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID

Placebo Arm Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
Total Total of all reporting groups

Baseline Measures
   Intensive HAART   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   16   32 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Full Range)
 34 
 (22 to 59) 
 30 
 (23 to 49) 
 32 
 (22 to 59) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   16   16   32 
Region of Enrollment 
[Units: Participants]
     
Canada   16   16   32 


  Outcome Measures

1.  Primary:   Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.   [ Time Frame: Baseline to Week 48 ]


  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: Mario Ostrowski, Principal Investigator, Professor of Medicine
Organization: University of Toronto
phone: 416-946-5805
e-mail: mario.ostrowski@gmail.com



Responsible Party: Mario Ostrowski, University of Toronto
ClinicalTrials.gov Identifier: NCT01154673     History of Changes
Obsolete Identifiers: NCT01101516
Other Study ID Numbers: 041009
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: October 26, 2015
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016