Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected patients with hepatitis co-infection | HIV-infected patients with co-infections of Hepatitis B or Hepatitis C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir (Kaletra) | Drug | 3 capsules 2xdaily or 2 tablets 2xdaily Kaletra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented. | Baseline |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented. | Week 4 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented. | Week 12 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented. | Week 24 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
Not provided
Not provided
Not provided
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Simianer, MD | Abbott Germany, Medical Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27575 | Berlin | 10243 | Germany | |||
| Site Reference ID/Investigator# 27592 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HIV-infected Participants With Hepatitis Co-infection | HIV-infected participants with co-infections of hepatitis B or hepatitis C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HIV-infected Participants With Hepatitis Co-infection | HIV-infected participants with co-infections of hepatitis B or hepatitis C. |
| 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 | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline. | Posted | Mean | Standard Deviation | U/liter | Baseline |
|
Investigators were instructed to report adverse events throughout the study (up to 3 years).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV-infected Participants With Hepatitis Co-infection | HIV-infected participants with co-infections of hepatitis B or hepatitis C. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| antiviral drug level above therapeutic | Investigations | Raw (uncoded) terms | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 36 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented. | Week 48 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented. | Week 60 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented. | Week 72 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented. | Week 84 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented. | Week 96 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented. | Week 108 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented. | Week 120 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented. | Week 132 |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented. | Week 144 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented. | Baseline |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented. | Week 4 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented. | Week 12 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented. | Week 24 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented. | Week 36 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented. | Week 48 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented. | Week 60 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented. | Week 72 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented. | Week 84 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented. | Week 96 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented. | Week 108 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented. | Week 120 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented. | Week 132 |
| Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented. | Week 144 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented. | Baseline |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented. | Week 4 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented. | Week 12 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented. | Week 24 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented. | Week 36 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented. | Week 48 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented. | Week 60 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented. | Week 72 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented. | Week 84 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented. | Week 96 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented. | Week 108 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented. | Week 120 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented. | Week 132 |
| CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented. | Week 144 |
| Berlin |
| 10961 |
| Germany |
| Site Reference ID/Investigator# 27588 | Dortmund | 44137 | Germany |
| Site Reference ID/Investigator# 27583 | Frankfurt | 60311 | Germany |
| Site Reference ID/Investigator# 27587 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 27607 | Hamburg | 20099 | Germany |
| Site Reference ID/Investigator# 5355 | Krefeld | 47800 | Germany |
| Site Reference ID/Investigator# 27604 | Münster | 48149 | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hepatitis Co-infection | The number of participants with hepatitis B or hepatitis C co-infection. | Number | participants |
|
| Duration of HIV infection | How long participants had been diagnosed with HIV infection at Baseline. Based on 32 participants. | Mean | Standard Deviation | years |
|
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection. |
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4. | Posted | Mean | Standard Deviation | U/liter | Week 4 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12. | Posted | Mean | Standard Deviation | U/liter | Week 12 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24. | Posted | Mean | Standard Deviation | U/liter | Week 24 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36. | Posted | Mean | Standard Deviation | U/liter | Week 36 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48. | Posted | Mean | Standard Deviation | U/liter | Week 48 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60. | Posted | Mean | Standard Deviation | U/liter | Week 60 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72. | Posted | Mean | Standard Deviation | U/liter | Week 72 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84. | Posted | Mean | Standard Deviation | U/liter | Week 84 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96. | Posted | Mean | Standard Deviation | U/liter | Week 96 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108. | Posted | Mean | Standard Deviation | U/liter | Week 108 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120. | Posted | Mean | Standard Deviation | U/liter | Week 120 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132. | Posted | Mean | Standard Deviation | U/liter | Week 132 |
|
|
|
| Primary | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented. | Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144. | Posted | Mean | Standard Deviation | U/liter | Week 144 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented. | Participants with HIV-1 RNA results at Baseline. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented. | Participants with HIV-1 RNA results at Week 4. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 4 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented. | Participants with HIV-1 RNA results at Week 12. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 12 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented. | Participants with HIV-1 RNA results at Week 24. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 24 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented. | Participants with HIV-1 RNA results at Week 36. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 36 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented. | Participants with HIV-1 RNA results at Week 48. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 48 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented. | Participants with HIV-1 RNA results at Week 60. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 60 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented. | Participants with HIV-1 RNA results at Week 72. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 72 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented. | Participants with HIV-1 RNA results at Week 84. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 84 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented. | Participants with HIV-1 RNA results at Week 96. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 96 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented. | Participants with HIV-1 RNA results at Week 108. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 108 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented. | Participants with HIV-1 RNA results at Week 120. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 120 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented. | Participants with HIV-1 RNA results at Week 132. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 132 |
|
|
|
| Primary | Viral Load | The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented. | Participants with HIV-1 RNA results at Week 144. | Posted | Mean | Standard Deviation | log10 copies/mL | Week 144 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented. | All participants with CD4+ cell count measurements at Baseline are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Baseline |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented. | All participants with CD4+ cell count measurements at Week 4 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 4 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented. | All participants with CD4+ cell count measurements at Week 12 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 12 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented. | All participants with CD4+ cell count measurements at Week 24 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 24 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented. | All participants with CD4+ cell count measurements at Week 36 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 36 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented. | All participants with CD4+ cell count measurements at Week 48 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 48 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented. | All participants with CD4+ cell count measurements at Baseline are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 60 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented. | All participants with CD4+ cell count measurements at Week 72 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 72 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented. | All participants with CD4+ cell count measurements at Week 84 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 84 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented. | All participants with CD4+ cell count measurements at Week 96 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 96 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented. | All participants with CD4+ cell count measurements at Week 108 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 108 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented. | All participants with CD4+ cell count measurements at Week 120 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 120 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented. | All participants with CD4+ cell count measurements at Week 132 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 132 |
|
|
|
| Primary | CD4 Cell Count | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented. | All participants with CD4+ cell count measurements at Week 144 are included. | Posted | Mean | Standard Deviation | CD4+ cells/μL | Week 144 |
|
|
|
| 0 |
| 33 |
| 1 |
| 33 |
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.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |