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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:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00357552
First received: July 25, 2006
Last updated: January 10, 2017
Last verified: January 2017
Results First Received: 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
  Hide Participant Flow

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
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.

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
  Show All Outcome Measures

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 ]

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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
Measure Description 25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.
Time Frame Study entry to Week 104  

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 participants enrolled.

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 
Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure. 
[Units: Weeks]
Number (95% Confidence Interval)
 48.0 
 (40.0 to 80.0) 

No statistical analysis provided for Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.



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