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Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00357552
First received: July 25, 2006
Last updated: August 23, 2012
Last verified: August 2012
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lopinavir/Ritonavir

  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
LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.

Participant Flow for 3 periods

Period 1:   Screening
    LPV/r Monotherapy  
STARTED     207 [1]
COMPLETED     123 [2]
NOT COMPLETED     84  
Did not meet eligibility criteria                 84  
[1] The number of participants who started this period, is the number of participants who screened.
[2] The number of participants who completed this period, is the number of participants who enrolled.

Period 2:   Weeks 0 to 24
    LPV/r Monotherapy  
STARTED     123  
COMPLETED     122 [1]
NOT COMPLETED     1  
Death                 1  
[1] One subject died prior to week 24.

Period 3:   Weeks 24 to 104
    LPV/r Monotherapy  
STARTED     122  
COMPLETED     117  
NOT COMPLETED     5  
Death                 3  
Not able to get to clinic                 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
LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.

Baseline Measures
    LPV/r Monotherapy  
Number of Participants  
[units: participants]
  123  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     123  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  39.4  ± 8.2  
Gender  
[units: participants]
 
Female     70  
Male     53  
Region of Enrollment  
[units: participants]
 
South Africa     22  
Thailand     24  
India     12  
Malawi     40  
Tanzania     25  



  Outcome Measures
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1.  Primary:   Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy   [ Time Frame: From study entry to week 24 ]

2.  Primary:   Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.   [ Time Frame: From study entry to week 24 ]
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Measure Type Primary
Measure Title Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
Measure Description Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time Frame From study entry to week 24  
Safety Issue Yes  

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.
All enrolled individuals.

Reporting Groups
  Description
LPV/r Monotherapy Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.

Measured Values
    LPV/r Monotherapy  
Number of Participants Analyzed  
[units: participants]
  123  
Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.  
[units: cumulative probability of grade 3 or 4]
Number ( 95% Confidence Interval )
  0.23  
  ( 0.16 to 0.31 )  

No statistical analysis provided for Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.



3.  Secondary:   Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.   [ Time Frame: Screening ]

4.  Secondary:   Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.   [ Time Frame: At time of virologic failure ]

5.  Secondary:   Percentage of Subjects Reporting Not Skipping Medications in the Last Month.   [ Time Frame: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24 ]

6.  Secondary:   Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.   [ Time Frame: Study entry to Week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   Yes

7.  Secondary:   HIV-related Diagnoses and Clinical Events   [ Time Frame: Study entry to week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   No

8.  Secondary:   Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification   [ Time Frame: From LPV/r intensification to week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   Yes

9.  Secondary:   Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and weeks 24 and 48 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   No

10.  Secondary:   HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and virologic failure ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   No

11.  Secondary:   Plasma HIV-1 RNA Levels Less Than 50 Copies/ml From Study Entry to Week 104.   [ Time Frame: From study entry to week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2010   Safety Issue:   No

12.  Secondary:   Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104   [ Time Frame: From study entry to week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   Safety Issue:   No

13.  Secondary:   Change in CD4+ Cell Counts From Baseline to Week 104   [ Time Frame: From study entry to week 104 ]
Results not yet reported.   Anticipated Reporting Date:   10/2012   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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: 6174322829
e-mail: CBAR.ClincalTrials.Gov@sdac.harvard.edu


Publications of Results:
Other Publications:

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00357552     History of Changes
Other Study ID Numbers: ACTG A5230, 1U01AI068636
Study First Received: July 25, 2006
Results First Received: May 23, 2012
Last Updated: August 23, 2012
Health Authority: United States: Federal Government