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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Gilead Sciences | INDUSTRY |
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The purposes of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truvada/Kaletra CD4<100 | Other | All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4<100 cells/cu mm |
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| Truvada/Kaletra CD4>/=100 | Other | All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4>/=100 cells/cu mm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truvada (tenofovir/emtricitabine) | Drug | Tenofovir/emtricitabine fixed dose combination once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom Score | AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 Physical Capacity Score | Measure of physical function out of 100. Lower score means less physical capacity. | 4 weeks |
| SF-12 Mental Capacity Score | Measure of mental functioning where lower is better out of a scale of 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl J Fichtenbaum, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati AIDS Clinical Trials Unit | Cincinnati | Ohio | 45267 | United States |
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Patients were recruited from Academic HIV practice from October 2005 through March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Truvada/Kaletra | All participants received the same treatment. This was a single arm study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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All participants received truvada and kaletra in this trial
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| Kaletra (lopinavir/ritonavir) | Drug | Lopinavir/ritonavir 400/100 mg twice daily |
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| 4 weeks |
| IL-1 Beta | Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| IL-4 | Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| IL-6 | Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| IL-7 | Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| IL-8 | Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| IL-10 | Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| TNF Alpha | Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| INF Gamma | Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Truvada/Kaletra CD4<100 | Group with CD4 lymphocyte count less than 100 cell/cu mm treated with truvada/kaletra |
| BG001 | Truvada/Kaletra CD4>/=100 | Group with CD4 lymphocyte count greater than or equal to 100 cell/cu mm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Symptom Score | AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale. | Posted | Median | Inter-Quartile Range | units on a scale | Week 4 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SF-12 Physical Capacity Score | Measure of physical function out of 100. Lower score means less physical capacity. | Those with lower CD4 at baseline compared to those with a higher CD4 count. | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SF-12 Mental Capacity Score | Measure of mental functioning where lower is better out of a scale of 100. | lower CD4 count at baseline compared to higher CD4 counts | Posted | Median | Inter-Quartile Range | score on a scale | 4 weeks |
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| Secondary | IL-1 Beta | Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | IL-4 | Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| Secondary | IL-6 | Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| Secondary | IL-7 | Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | IL-8 | Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| Secondary | IL-10 | Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
|
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| Secondary | TNF Alpha | Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | INF Gamma | Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
|
|
6 months
All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline <100 or greater than/equal to 100 cells/cu mm
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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 | Truvada/Kaletra CD4<100 | 0 | 26 | 1 | 26 | 26 | 26 | |
| EG001 | Truvada/Kaletra CD4>/=100 | 0 | 34 | 0 | 34 | 34 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral neuropathy | Nervous system disorders | Systematic Assessment | Onset of numbness, tingling and pain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fevers | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Night Sweats | General disorders | Systematic Assessment |
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Small study of 60 subjects. Some subjects did not complete all study visits limiting data available for each time point.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carl J. Fichtenbaum | University of Cincinnati | 513-584-6361 | carl.fichtenbaum@uc.edu |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| C558899 | lopinavir-ritonavir drug combination |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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| >=65 years |
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| Male |
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