Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effects of Intensive cART During Acute/Early HIV Infection

This study has been completed.
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Maple Leaf Medical Clinic
Information provided by (Responsible Party):
Mario Ostrowski, University of Toronto
ClinicalTrials.gov Identifier:
NCT01154673
First received: June 29, 2010
Last updated: March 4, 2016
Last verified: March 2016
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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
Study First Received: June 29, 2010
Results First Received: October 26, 2015
Last Updated: March 4, 2016
Health Authority: Canada: Health Canada