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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357552
First Posted: July 27, 2006
Last Update Posted: February 28, 2017
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.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
Results First Submitted: May 23, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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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 
Overall Participants Analyzed 
[Units: Participants]
 123 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      123 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (8.2) 
Gender 
[Units: Participants]
Count of Participants
 
Female      70  56.9% 
Male      53  43.1% 
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 ]
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Measure Type Primary
Measure Title Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
Measure Description Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL.
Time Frame From study entry to week 24  

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 
Participants Analyzed 
[Units: Participants]
 123 
Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy 
[Units: Percentage of enrolled subjects]
Number (90% Confidence Interval)
 87 
 (81 to 92) 


Statistical Analysis 1 for Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
Groups [1] LPV/r Monotherapy
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] confidence interval
proportion [4] 87
90% Confidence Interval 81 to 92
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.
[4] Other relevant estimation information:
  exact confidence interval



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 ]

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

4.  Secondary:   Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.   [ Time Frame: Study entry to Week 104 ]

5.  Secondary:   Number of Participants With Study-targeted Diagnoses and Clinical Events   [ Time Frame: Study entry to week 104 ]

6.  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 ]

7.  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 ]

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 ]

9.  Secondary:   Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and weeks 24 and 48 ]

10.  Secondary:   HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma   [ Time Frame: At study entry and virologic failure ]

11.  Secondary:   Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104   [ Time Frame: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104 ]

12.  Secondary:   Change in CD4+ Cell Counts From Study Entry to Week 104   [ Time Frame: Study entry and week 104 ]


  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: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00357552     History of Changes
Other Study ID Numbers: ACTG A5230
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: July 25, 2006
First Posted: July 27, 2006
Results First Submitted: May 23, 2012
Results First Posted: September 25, 2012
Last Update Posted: February 28, 2017