Trial Outcomes & Findings for Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China (NCT NCT01074931)
NCT ID: NCT01074931
Last Updated: 2011-08-03
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
98 participants
Primary outcome timeframe
Month 3, 6, 12, 18
Results posted on
2011-08-03
Participant Flow
Participant milestones
| Measure |
Lopinavir/Ritonavir Group
Adult participants with HIV-1 infection taking lopinavir/ritonavir
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Lopinavir/Ritonavir Group
Adult participants with HIV-1 infection taking lopinavir/ritonavir
|
|---|---|
|
Overall Study
Economic reasons
|
1
|
|
Overall Study
Death
|
5
|
Baseline Characteristics
Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China
Baseline characteristics by cohort
| Measure |
Lopinavir/Ritonavir Group
n=98 Participants
Adult participants with HIV-1 infection taking lopinavir/ritonavir
|
|---|---|
|
Age Continuous
|
39.86 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
98 participants
n=5 Participants
|
|
Age at HIV-1 Diagnosis
|
36.35 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Participant Classification
Treatment-experienced
|
90 Participants
n=5 Participants
|
|
Participant Classification
Treatment-naive
|
8 Participants
n=5 Participants
|
|
WHO Clinical Staging
Stage 1 (asymptomatic)
|
8 Participants
n=5 Participants
|
|
WHO Clinical Staging
Stage 2 (mild symptoms)
|
22 Participants
n=5 Participants
|
|
WHO Clinical Staging
Stage 3 (advanced symptoms)
|
32 Participants
n=5 Participants
|
|
WHO Clinical Staging
Stage 4 (severe symptoms)
|
36 Participants
n=5 Participants
|
|
Body Weight
|
56.91 kilograms
STANDARD_DEVIATION 11.14 • n=5 Participants
|
|
Lipodystrophy
Lipodystrophy not present
|
56 Participants
n=5 Participants
|
|
Lipodystrophy
Mild lipodystrophy present
|
30 Participants
n=5 Participants
|
|
Lipodystrophy
Moderate lipodystrophy present
|
11 Participants
n=5 Participants
|
|
Lipodystrophy
Severe lipodystrophy present
|
1 Participants
n=5 Participants
|
|
Antiretroviral Treatment within Previous 6 Months
Yes
|
89 Particpants
n=5 Participants
|
|
Antiretroviral Treatment within Previous 6 Months
No
|
8 Particpants
n=5 Participants
|
|
Antiretroviral Treatment within Previous 6 Months
Not reported
|
1 Particpants
n=5 Participants
|
|
Other Chronic Diseases Present
No
|
67 participants
n=5 Participants
|
|
Other Chronic Diseases Present
Yes
|
29 participants
n=5 Participants
|
|
Other Chronic Diseases Present
Not reported
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3, 6, 12, 18Population: All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=1 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
n=66 Participants
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
Evolution of the HIV Viral Response
Viral load detectable at Visit 1
|
0 participant
|
3 participant
|
|
Evolution of the HIV Viral Response
Viral load detectable at Visit 2
|
0 participant
|
12 participant
|
|
Evolution of the HIV Viral Response
Viral load detectable at Visit 3
|
0 participant
|
5 participant
|
|
Evolution of the HIV Viral Response
Viral load detectable at Visit 4
|
0 participant
|
5 participant
|
|
Evolution of the HIV Viral Response
Viral load undetectable at Baseline
|
1 participant
|
15 participant
|
|
Evolution of the HIV Viral Response
Viral load undetectable at Visit 4
|
0 participant
|
25 participant
|
|
Evolution of the HIV Viral Response
Viral load detectable at Baseline
|
0 participant
|
51 participant
|
|
Evolution of the HIV Viral Response
Viral load undetectable at Visit 1
|
0 participant
|
22 participant
|
|
Evolution of the HIV Viral Response
Viral load undetectable at Visit 2
|
0 participant
|
39 participant
|
|
Evolution of the HIV Viral Response
Viral load undetectable at Visit 3
|
1 participant
|
47 participant
|
PRIMARY outcome
Timeframe: Month 3, 6, 12, 18Population: Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=8 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
n=90 Participants
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
Evolution of CD4 Count
CD4+ count at Baseline
|
101.00 cells per cmm
Standard Deviation 107.94
|
249.03 cells per cmm
Standard Deviation 196.40
|
|
Evolution of CD4 Count
CD4+ count at Visit 1
|
136.67 cells per cmm
Standard Deviation 85.20
|
285.96 cells per cmm
Standard Deviation 164.05
|
|
Evolution of CD4 Count
CD4+ count at Visit 2
|
200.57 cells per cmm
Standard Deviation 123.25
|
317.10 cells per cmm
Standard Deviation 180.26
|
|
Evolution of CD4 Count
CD4+ count at Visit 3
|
200.00 cells per cmm
Standard Deviation 112.56
|
378.56 cells per cmm
Standard Deviation 198.35
|
|
Evolution of CD4 Count
CD4+ count at Visit 4
|
239.00 cells per cmm
Standard Deviation 124.40
|
413.77 cells per cmm
Standard Deviation 209.96
|
PRIMARY outcome
Timeframe: Month 3, 6, 12, 18Population: All participants taking at least one dose of lopinavir/ritonavir.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=98 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
Evolution of the Tolerance Issues
Lopinavir/ritonavir not tolerated at Visit 1
|
2 Participants
|
—
|
|
Evolution of the Tolerance Issues
Lopinavir/ritonavir not tolerated at Visit 2
|
0 Participants
|
—
|
|
Evolution of the Tolerance Issues
Lopinavir/ritonavir not tolerated at Visit 3
|
0 Participants
|
—
|
|
Evolution of the Tolerance Issues
Lopinavir/ritonavir not tolerated at Visit 4
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 3, 6, 12, 18Population: All participants who took at least one dose of lopinavir/ritonavir.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=98 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Total Missed Doses
|
49 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
d) Missed doses reported at Visit 4
|
10 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Discontinued lopinavir/ritonavir therapy
|
6 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
a) Discontinued due to serious adverse event
|
5 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Interrupted lopinavir/ritonavir therapy
|
4 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
a) Interrupted due to adverse event
|
2 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
a) Switch from capsule to tablet at Visit 1
|
35 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
a) Missed doses reported at Visit 1
|
9 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
b) Missed doses reported at Visit 2
|
13 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
c) Missed doses reported at Visit 3
|
17 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
b) Discontinued due to economic reasons
|
1 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
b) Required treatment with prohibited medication
|
1 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
c) Away because of work
|
1 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
Therapy change: Switch from capsule to tablet
|
51 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
b) Switch from capsule to tablet at Visit 2
|
12 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
c) Switch from capsule to tablet at Visit 3
|
4 Participants
|
—
|
|
Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
d) Switch from capsule to tablet at Visit 4
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 3, 6, 12, 18Population: 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).
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=98 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
a) Improved
|
9 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
b) Unchanged
|
75 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
c) Worsened
|
0 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Lipodystrophy: Visit 2 evaluation
|
88 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Lipodystrophy: Visit 3 evaluation
|
87 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Non-serious adverse events
|
1 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Serious adverse events
|
8 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Lipodystrophy: Visit 1 evaluation
|
90 Participants
|
—
|
|
Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
Lipodystrophy: Visit 4 evaluation
|
84 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 3, 6, 12, 18Population: All participants who took at least one dose of lopinavir/ritonavir.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir: Treatment-naive
n=8 Participants
The subgroup of participants who had not received prior antiretroviral drug therapy.
|
Lopinavir/Ritonavir: Treatment-experienced
n=90 Participants
The subgroup of participants who had previously received antiretroviral drug therapy.
|
|---|---|---|
|
The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment
|
1 Participants
|
5 Participants
|
Adverse Events
Lopinavir/Ritonavir Group
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lopinavir/Ritonavir Group
n=98 participants at risk
Adult participants with HIV-1 infection taking lopinavir/ritonavir
|
|---|---|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Hepatobiliary disorders
Liver and kidney syndromes
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Hepatobiliary disorders
Hepatocirrhosis
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Hepatobiliary disorders
Serious hepatitis
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Respiratory, thoracic and mediastinal disorders
Chest distress
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Respiratory, thoracic and mediastinal disorders
Severe pneumonia
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Renal and urinary disorders
Port colored urine
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Immune system disorders
Infections
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Immune system disorders
Tuberculosis
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
General disorders
Fever
|
2.0%
2/98 • Number of events 2 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
General disorders
Death
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
General disorders
Asthenia
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
General disorders
Wasting syndrome
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Nervous system disorders
Lethargy
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
|
Nervous system disorders
Somnolence
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
Other adverse events
| Measure |
Lopinavir/Ritonavir Group
n=98 participants at risk
Adult participants with HIV-1 infection taking lopinavir/ritonavir
|
|---|---|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
1.0%
1/98 • Number of events 1 • 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.
The safety population included all participants who took at least 1 dose of lopinavir/ritonavir.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER