Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margaret A. Fischl, M.D., University of Miami
ClinicalTrials.gov Identifier:
NCT00654147
First received: April 2, 2008
Last updated: July 11, 2015
Last verified: July 2015
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir & Lopinavir/ritonavir
Drug: Raltegravir and emtricitabine/tenofovir

  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
Patients were randomly assigned to receive one of two regimens Raltegravir (Isentress, Merck & Company) 400 mg twice daily with either Lopinavir/ritonavir (Kaletra, Abbott Laboratories) 200 mg/100 mg twice daily or with emtricitabine/tenofovir (Truvada, Gilead Sciences) 200 mg/100 mg twice daily.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with acute or recent HIV-1 infection, major resistance-associated mutation on any genotype performed at any time prior to study entry, serious illness requiring systemic treatment and/or hospitalization within 7 days of study entry, HBsAg positivity, acute hepatitis of any etiology, clinically significant liver disease were excluded

Reporting Groups
  Description
Raltegravir & Lopinavir/Ritonavir

Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir & Emtricitabine/Tenofovir

Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48


Participant Flow:   Overall Study
    Raltegravir & Lopinavir/Ritonavir     Raltegravir & Emtricitabine/Tenofovir  
STARTED     21     23  
COMPLETED     19     19  
NOT COMPLETED     2     4  



  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 & Lopinavir/Ritonavir

Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks

Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks

Raltegravir & Emtricitabine/Tenofovir

Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks

Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48

Total Total of all reporting groups

Baseline Measures
    Raltegravir & Lopinavir/Ritonavir     Raltegravir & Emtricitabine/Tenofovir     Total  
Number of Participants  
[units: participants]
  21     23     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     23     44  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     1     4  
Male     18     22     40  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     13     15     28  
Not Hispanic or Latino     8     8     16  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     9     7     16  
White     12     16     28  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     21     23     44  



  Outcome Measures
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1.  Primary:   Time to Confirmed Virologic Failure   [ Time Frame: weeks ]

2.  Primary:   Time to Virologic Failure   [ Time Frame: week 24 (up to 48 weeks) ]

3.  Secondary:   Study Medication Toxicity-related Discontinuation .   [ Time Frame: 48 weeks ]

4.  Secondary:   Weeks to HIV-1 RNA <200 Copies/ml   [ Time Frame: from date of treatment start to first week documented viral suppression ]

5.  Secondary:   Change From Baseline CD4+ and CD8+ Cell Counts   [ Time Frame: Baseline, Weeks 16 and 24 ]

6.  Secondary:   Study Medication Tolerability   [ Time Frame: date started study treatment to first week documented change study treatment up 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
Pilot study with 44 subjects and generalization f results is limited by the small sample size.


  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: Director AIDS Clinical Research Unit
Organization: University of Miami School of Medicine
phone: 305-243-3838
e-mail: mfischl@med.miami.edu


No publications provided


Responsible Party: Margaret A. Fischl, M.D., University of Miami
ClinicalTrials.gov Identifier: NCT00654147     History of Changes
Other Study ID Numbers: A009
Study First Received: April 2, 2008
Results First Received: January 20, 2015
Last Updated: July 11, 2015
Health Authority: United States: Institutional Review Board