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Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China

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ClinicalTrials.gov Identifier: NCT01074931
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : August 3, 2011
Last Update Posted : August 3, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Study Design Time Perspective: Prospective
Condition HIV-1 Infections
Intervention Drug: Lopinavir/ritonavir (Kaletra)
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description Adult participants with HIV-1 infection taking lopinavir/ritonavir
Period Title: Overall Study
Started 98
Completed 92
Not Completed 6
Reason Not Completed
Economic reasons             1
Death             5
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description Adult participants with HIV-1 infection taking lopinavir/ritonavir
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
39.86  (10.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
27
  27.6%
Male
71
  72.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 98 participants
98
Age at HIV-1 Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
36.35  (10.89)
[1]
Measure Description: The mean age at which participants were diagnosed with HIV-1, based on 97 participants.
Participant Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
Treatment-experienced 90
Treatment-naive 8
[1]
Measure Description: Participants were classified as either treatment-naive or treatment experienced.
WHO Clinical Staging   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
Stage 1 (asymptomatic) 8
Stage 2 (mild symptoms) 22
Stage 3 (advanced symptoms) 32
Stage 4 (severe symptoms) 36
[1]
Measure Description: Participants were staged according to the World Health Organization (WHO) clinical classification of established HIV infection: Stage 1 (asymptomatic), Stage 2 (mild symptoms), Stage 3 (advanced symptoms), and Stage 4 (severe symptoms).
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 98 participants
56.91  (11.14)
[1]
Measure Description: Participant body weight at study entry.
Lipodystrophy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
Lipodystrophy not present 56
Mild lipodystrophy present 30
Moderate lipodystrophy present 11
Severe lipodystrophy present 1
[1]
Measure Description: The presence and severity of lipodystrophy (abnormal body fat distribution) at study entry.
Antiretroviral Treatment within Previous 6 Months   [1] 
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 98 participants
Yes 89
No 8
Not reported 1
[1]
Measure Description: Whether or not the participant had antiretroviral treatment within 6 months prior to study entry.
Other Chronic Diseases Present   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
No 67
Yes 29
Not reported 2
[1]
Measure Description: Whether or not the participant had a chronic disease that had developed previously or was identified at study entry.
1.Primary Outcome
Title Evolution of the HIV Viral Response
Hide Description The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.
Arm/Group Title Lopinavir/Ritonavir: Treatment-naive Lopinavir/Ritonavir: Treatment-experienced
Hide Arm/Group Description:
The subgroup of participants who had not received prior antiretroviral drug therapy.
The subgroup of participants who had previously received antiretroviral drug therapy.
Overall Number of Participants Analyzed 1 66
Measure Type: Number
Unit of Measure: participant
Viral load detectable at Baseline 0 51
Viral load detectable at Visit 1 0 3
Viral load detectable at Visit 2 0 12
Viral load detectable at Visit 3 0 5
Viral load detectable at Visit 4 0 5
Viral load undetectable at Baseline 1 15
Viral load undetectable at Visit 1 0 22
Viral load undetectable at Visit 2 0 39
Viral load undetectable at Visit 3 1 47
Viral load undetectable at Visit 4 0 25
2.Primary Outcome
Title Evolution of CD4 Count
Hide Description The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.
Arm/Group Title Lopinavir/Ritonavir: Treatment-naive Lopinavir/Ritonavir: Treatment-experienced
Hide Arm/Group Description:
The subgroup of participants who had not received prior antiretroviral drug therapy.
The subgroup of participants who had previously received antiretroviral drug therapy.
Overall Number of Participants Analyzed 8 90
Mean (Standard Deviation)
Unit of Measure: cells per cmm
CD4+ count at Baseline 101.00  (107.94) 249.03  (196.40)
CD4+ count at Visit 1 136.67  (85.20) 285.96  (164.05)
CD4+ count at Visit 2 200.57  (123.25) 317.10  (180.26)
CD4+ count at Visit 3 200.00  (112.56) 378.56  (198.35)
CD4+ count at Visit 4 239.00  (124.40) 413.77  (209.96)
3.Primary Outcome
Title Evolution of the Tolerance Issues
Hide Description At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants taking at least one dose of lopinavir/ritonavir.
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description:
Adult participants with HIV-1 infection taking lopinavir/ritonavir
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: Participants
Lopinavir/ritonavir not tolerated at Visit 1 2
Lopinavir/ritonavir not tolerated at Visit 2 0
Lopinavir/ritonavir not tolerated at Visit 3 0
Lopinavir/ritonavir not tolerated at Visit 4 0
4.Secondary Outcome
Title Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Hide Description Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of lopinavir/ritonavir.
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description:
Adult participants with HIV-1 infection taking lopinavir/ritonavir
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: Participants
Total Missed Doses 49
a) Missed doses reported at Visit 1 9
b) Missed doses reported at Visit 2 13
c) Missed doses reported at Visit 3 17
d) Missed doses reported at Visit 4 10
Discontinued lopinavir/ritonavir therapy 6
a) Discontinued due to serious adverse event 5
b) Discontinued due to economic reasons 1
Interrupted lopinavir/ritonavir therapy 4
a) Interrupted due to adverse event 2
b) Required treatment with prohibited medication 1
c) Away because of work 1
Therapy change: Switch from capsule to tablet 51
a) Switch from capsule to tablet at Visit 1 35
b) Switch from capsule to tablet at Visit 2 12
c) Switch from capsule to tablet at Visit 3 4
d) Switch from capsule to tablet at Visit 4 0
5.Secondary Outcome
Title Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Hide Description The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description:
Adult participants with HIV-1 infection taking lopinavir/ritonavir
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: Participants
Non-serious adverse events 1
Serious adverse events 8
Lipodystrophy: Visit 1 evaluation 90
a) Improved 24
b) Unchanged 65
c) Worsened 1
Lipodystrophy: Visit 2 evaluation 88
a) Improved 8
b) Unchanged 78
c) Worsened 2
Lipodystrophy: Visit 3 evaluation 87
a) Improved 8
b) Unchanged 79
c) Worsened 0
Lipodystrophy: Visit 4 evaluation 84
a) Improved 9
b) Unchanged 75
c) Worsened 0
6.Secondary Outcome
Title The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment
Hide Description As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.
Time Frame Month 3, 6, 12, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of lopinavir/ritonavir.
Arm/Group Title Lopinavir/Ritonavir Group: Treatment-naive Lopinavir/Ritonavir Group: Treatment-experienced
Hide Arm/Group Description:
The subgroup of participants who had not received prior antiretroviral drug therapy.
The subgroup of participants who had previously received antiretroviral drug therapy.
Overall Number of Participants Analyzed 8 90
Measure Type: Number
Unit of Measure: Participants
1 5
Time Frame All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of lopinavir/ritonavir.
Adverse Event Reporting Description The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
 
Arm/Group Title Lopinavir/Ritonavir Group
Hide Arm/Group Description Adult participants with HIV-1 infection taking lopinavir/ritonavir
All-Cause Mortality
Lopinavir/Ritonavir Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lopinavir/Ritonavir Group
Affected / at Risk (%) # Events
Total   8/98 (8.16%)    
Blood and lymphatic system disorders   
Anemia  1  2/98 (2.04%)  2
Gastrointestinal disorders   
Diarrhea  1  1/98 (1.02%)  1
General disorders   
Fever  1  2/98 (2.04%)  2
Death  1  1/98 (1.02%)  1
Asthenia  1  1/98 (1.02%)  1
Wasting syndrome  1  1/98 (1.02%)  1
Hepatobiliary disorders   
Liver and kidney syndromes  1  1/98 (1.02%)  1
Hepatocirrhosis  1  1/98 (1.02%)  1
Serious hepatitis  1  1/98 (1.02%)  1
Immune system disorders   
Infections  1  2/98 (2.04%)  2
Tuberculosis  1  2/98 (2.04%)  2
Metabolism and nutrition disorders   
Hypoproteinemia  1  1/98 (1.02%)  1
Musculoskeletal and connective tissue disorders   
Bone fracture  1  1/98 (1.02%)  1
Nervous system disorders   
Hepatic encephalopathy  1  1/98 (1.02%)  1
Lethargy  1  1/98 (1.02%)  1
Somnolence  1  1/98 (1.02%)  1
Renal and urinary disorders   
Port colored urine  1  1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/98 (1.02%)  1
Cough  1  2/98 (2.04%)  2
Chest distress  1  1/98 (1.02%)  1
Severe pneumonia  1  2/98 (2.04%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lopinavir/Ritonavir Group
Affected / at Risk (%) # Events
Total   1/98 (1.02%)    
Metabolism and nutrition disorders   
Hyperlipidemia  1  1/98 (1.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
The location of lipodystrophy was not summarized as there was not a place to record the information on the case report form. Too few participants withdrew from treatment to conduct planned analyses of duration to adverse event(s)/discontinuation.
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Yue Kang, Abbott China
ClinicalTrials.gov Identifier: NCT01074931     History of Changes
Other Study ID Numbers: P10-398
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: May 20, 2011
Results First Posted: August 3, 2011
Last Update Posted: August 3, 2011