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This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced patients infected with human immunodeficiency virus type 1 (HIV-1) in China.
Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and tolerance of anti-HIV strategies in real life is still a major challenge in the management of HIV-infected patients who are on a life-long therapy, especially in China.
This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1 strategies to Chinese experts and benefits Chinese HIV-1 infected patients.
It is planned to enroll approximately 100 patients in total. This will be a multicenter post-marketing observational study in China mainland.
Each patient will be observed during his/her lopinavir/ritonavir - containing treatment regimen for a maximum period of 18 months.
If the physician decides to permanently discontinue lopinavir/ritonavir before the end of the planned observational period of 18 months, the reason for the discontinuation and the new treatment regimen prescribed will be documented. The next routine follow-up visit will be the termination visit for this patient in this study.
This post-marketing observational study will be conducted in a prospective, single-arm, multicenter format.
As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 18-month period, which defines the survey for each patient. For indicative purpose, follow-up of patients should enable approximately 4 patient visits during this period. These visits will take place at average intervals of 6 months, apart from the first visit following inclusion (usually at the end of the first 3 treatment months) and apart from visits required because of an intercurrent event. If treatment with lopinavir/ritonavir is discontinued, standard practice is to review the patient after a period of 3 months.
For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4" although numbers and dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a deviation of the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lopinavir/ritonavir group | This study is a non-interventional, observational study in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of China market authorization with regards to dose, population and indication. It is planned to enroll approximately 100 patients in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir (Kaletra) | Drug | Lopinavir/ritonavir(LPV/r) is an HIV protease inhibitor (PI) that is co-formulated with lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in LPV/r, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. The assignment of the patient to a lopinavir/ritonavir - containing regimen is not decided in advance by this protocol but falls within current practice and the prescription of lopinavir/ritonavir is clearly separated from the decision to include the patient in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the HIV Viral Response | 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. | Month 3, 6, 12, 18 |
| Evolution of CD4 Count | 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. | Month 3, 6, 12, 18 |
| Evolution of the Tolerance Issues | 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. | Month 3, 6, 12, 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen | 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. |
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Inclusion Criteria:
Patients infected by HIV-1 who are over 18 years old
Patients who belong to one of the following cohorts:
Exclusion Criteria:
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Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Jian LI, MD | Abbott (China) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 7244 | Guangdong | 510060 | China | |||
| Site Reference ID/Investigator# 27865 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lopinavir/Ritonavir Group | Adult participants with HIV-1 infection taking lopinavir/ritonavir |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lopinavir/Ritonavir Group | Adult participants with HIV-1 infection taking lopinavir/ritonavir |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evolution of the HIV Viral Response | 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. | All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing. | Posted | Number | participant | Month 3, 6, 12, 18 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lopinavir/Ritonavir Group | Adult participants with HIV-1 infection taking lopinavir/ritonavir |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoproteinemia | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipidemia | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Month 3, 6, 12, 18 |
| Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations | 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. | Month 3, 6, 12, 18 |
| The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment | 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. | Month 3, 6, 12, 18 |
| Kunming |
| 650118 |
| China |
| Site Reference ID/Investigator# 27864 | Shanghai | 201508 | China |
| Site Reference ID/Investigator# 27863 | Shenzhen | 518020 | China |
| Site Reference ID/Investigator# 27866 | Zhengzhou | 450061 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at HIV-1 Diagnosis | The mean age at which participants were diagnosed with HIV-1, based on 97 participants. | Mean | Standard Deviation | years |
|
| Participant Classification | Participants were classified as either treatment-naive or treatment experienced. | Number | Participants |
|
| WHO Clinical Staging | 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). | Number | Participants |
|
| Body Weight | Participant body weight at study entry. | Mean | Standard Deviation | kilograms |
|
| Lipodystrophy | The presence and severity of lipodystrophy (abnormal body fat distribution) at study entry. | Number | Participants |
|
| Antiretroviral Treatment within Previous 6 Months | Whether or not the participant had antiretroviral treatment within 6 months prior to study entry. | Number | Particpants |
|
| Other Chronic Diseases Present | Whether or not the participant had a chronic disease that had developed previously or was identified at study entry. | Number | participants |
|
| OG001 | Lopinavir/Ritonavir: Treatment-experienced | The subgroup of participants who had previously received antiretroviral drug therapy. |
|
|
| Primary | Evolution of CD4 Count | 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. | Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point. | Posted | Mean | Standard Deviation | cells per cmm | Month 3, 6, 12, 18 |
|
|
|
| Primary | Evolution of the Tolerance Issues | 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. | All participants taking at least one dose of lopinavir/ritonavir. | Posted | Number | Participants | Month 3, 6, 12, 18 |
|
|
|
| Secondary | Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen | 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. | All participants who took at least one dose of lopinavir/ritonavir. | Posted | Number | Participants | Month 3, 6, 12, 18 |
|
|
|
| Secondary | Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations | 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. | 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). | Posted | Number | Participants | Month 3, 6, 12, 18 |
|
|
|
| Secondary | The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment | 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. | All participants who took at least one dose of lopinavir/ritonavir. | Posted | Number | Participants | Month 3, 6, 12, 18 |
|
|
|
| 8 |
| 98 |
| 1 |
| 98 |
| Liver and kidney syndromes | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Hepatocirrhosis | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Serious hepatitis | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Chest distress | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Severe pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Port colored urine | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Infections | Immune system disorders | WHOART | Systematic Assessment |
|
| Tuberculosis | Immune system disorders | WHOART | Systematic Assessment |
|
| Fever | General disorders | WHOART | Systematic Assessment |
|
| Death | General disorders | WHOART | Systematic Assessment |
|
| Asthenia | General disorders | WHOART | Systematic Assessment |
|
| Wasting syndrome | General disorders | WHOART | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | WHOART | Systematic Assessment |
|
| Lethargy | Nervous system disorders | WHOART | Systematic Assessment |
|
| Somnolence | Nervous system disorders | WHOART | Systematic Assessment |
|
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.
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| CD4+ count at Visit 2 |
|
| CD4+ count at Visit 3 |
|
| CD4+ count at Visit 4 |
|
| Title | Measurements |
|---|---|
|
| Lopinavir/ritonavir not tolerated at Visit 4 |
|
| Title | Measurements |
|---|---|
|
| c) Missed doses reported at Visit 3 |
|
| d) Missed doses reported at Visit 4 |
|
| Discontinued lopinavir/ritonavir therapy |
|
| a) Discontinued due to serious adverse event |
|
| b) Discontinued due to economic reasons |
|
| Interrupted lopinavir/ritonavir therapy |
|
| a) Interrupted due to adverse event |
|
| b) Required treatment with prohibited medication |
|
| c) Away because of work |
|
| Therapy change: Switch from capsule to tablet |
|
| a) Switch from capsule to tablet at Visit 1 |
|
| b) Switch from capsule to tablet at Visit 2 |
|
| c) Switch from capsule to tablet at Visit 3 |
|
| d) Switch from capsule to tablet at Visit 4 |
|
| Title | Measurements |
|---|---|
|
| a) Improved |
|
| b) Unchanged |
|
| c) Worsened |
|
| Lipodystrophy: Visit 2 evaluation |
|
| a) Improved |
|
| b) Unchanged |
|
| c) Worsened |
|
| Lipodystrophy: Visit 3 evaluation |
|
| a) Improved |
|
| b) Unchanged |
|
| c) Worsened |
|
| Lipodystrophy: Visit 4 evaluation |
|
| a) Improved |
|
| b) Unchanged |
|
| c) Worsened |
|