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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: September 29, 2015
Last verified: September 2015
Results First Received: May 23, 2012  
Study Type: Interventional
Study Design: 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
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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.
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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.

Baseline Measures
   LPV/r Monotherapy 
Overall Participants Analyzed 
[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 ]

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:   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 ]

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

11.  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:   06/2016  

12.  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:   06/2016  


  Serious Adverse Events


  Other Adverse Events
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Time Frame From study entry up to 104 weeks.
Additional Description The protocol required reporting of all signs, symptoms and laboratory abnormalities >= grade 3 and any that led to a study treatment change, regardless of grade. The "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004 was used.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
LPV/r 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.

Other Adverse Events
    LPV/r
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   122/123 (99.19%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   8/123 (6.50%) 
Diarrhoea † 1   
# participants affected / at risk   13/123 (10.57%) 
Nausea † 1   
# participants affected / at risk   7/123 (5.69%) 
Vomiting † 1   
# participants affected / at risk   12/123 (9.76%) 
General disorders   
Chest pain † 1   
# participants affected / at risk   13/123 (10.57%) 
Pain † 1   
# participants affected / at risk   9/123 (7.32%) 
Pyrexia † 1   
# participants affected / at risk   27/123 (21.95%) 
Infections and infestations   
Malaria † 1   
# participants affected / at risk   11/123 (8.94%) 
Nasopharyngitis † 1   
# participants affected / at risk   8/123 (6.50%) 
Pneumonia bacterial † 1   
# participants affected / at risk   9/123 (7.32%) 
Upper respiratory tract infection † 1   
# participants affected / at risk   22/123 (17.89%) 
Urinary tract infection † 1   
# participants affected / at risk   7/123 (5.69%) 
Investigations   
Alanine aminotransferase increased † 1   
# participants affected / at risk   22/123 (17.89%) 
Aspartate aminotransferase increased † 1   
# participants affected / at risk   18/123 (14.63%) 
Blood albumin decreased † 1   
# participants affected / at risk   22/123 (17.89%) 
Blood alkaline phosphatase increased † 1   
# participants affected / at risk   10/123 (8.13%) 
Blood bicarbonate decreased † 1   
# participants affected / at risk   24/123 (19.51%) 
Blood bilirubin increased † 1   
# participants affected / at risk   7/123 (5.69%) 
Blood cholesterol increased † 1   
# participants affected / at risk   76/123 (61.79%) 
Blood glucose decreased † 1   
# participants affected / at risk   9/123 (7.32%) 
Blood glucose increased † 1   
# participants affected / at risk   31/123 (25.20%) 
Blood phosphorus decreased † 1   
# participants affected / at risk   39/123 (31.71%) 
Blood potassium decreased † 1   
# participants affected / at risk   18/123 (14.63%) 
Blood sodium decreased † 1   
# participants affected / at risk   62/123 (50.41%) 
Blood triglycerides increased † 1   
# participants affected / at risk   22/123 (17.89%) 
Haemoglobin decreased † 1   
# participants affected / at risk   15/123 (12.20%) 
Low density lipoprotein increased † 1   
# participants affected / at risk   54/123 (43.90%) 
Neutrophil count decreased † 1   
# participants affected / at risk   38/123 (30.89%) 
Platelet count decreased † 1   
# participants affected / at risk   10/123 (8.13%) 
White blood cell count decreased † 1   
# participants affected / at risk   19/123 (15.45%) 
Nervous system disorders   
Headache † 1   
# participants affected / at risk   21/123 (17.07%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   34/123 (27.64%) 
Oropharyngeal pain † 1   
# participants affected / at risk   13/123 (10.57%) 
Rhinorrhoea † 1   
# participants affected / at risk   7/123 (5.69%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 18.0



  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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