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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug948 | Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Wiki | 1.00 |
| drug3923 | Telehealth CBT Wiki | 1.00 |
| drug1427 | Etoposide (ET) Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This study was done to compare the safety and efficacy of three combination treatments for Kaposi's Sarcoma (KS) and AIDS: 1. Etoposide (ET) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) (ET+ART), 2. Bleomycin and Vincristine (BV) plus co-formulated EFV/FTC/TDF (BV+ART), 3. Paclitaxel (PTX) plus co-formulated EFV/FTC/TDF (PTX+ART).
Description: Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.
Measure: Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.
Measure: Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.
Measure: Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.
Measure: Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later.
Measure: Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later.
Measure: Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.
Measure: Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART Time: From study entry to week 12Description: KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.
Measure: Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART Time: From study entry to week 12Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48
Measure: Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48
Measure: Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48
Measure: Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48
Measure: Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.
Measure: Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.
Measure: Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.
Measure: Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.
Measure: Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART Time: From study entry to week 48Description: The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.
Measure: Cumulative Rate of Death for ET+ART vs. PTX+ART Time: From study entry to week 240Description: The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.
Measure: Cumulative Rate of Death for BV+ART vs PTX+ART Time: From study entry to week 240Description: Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented.
Measure: Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART Time: From study entry to week 240Description: Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented.
Measure: Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART Time: From study entry to week 240Description: The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Number of Participants With Objective Response for ET+ART vs. PTX+ART Time: From study entry up to week 144Description: The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Measure: Number of Participants With Objective Response for BV+ART vs. PTX+ART Time: From study entry up to week 144Description: Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.
Measure: Duration of Objective Response for ET+ART vs. PTX+ART Time: From study entry up to week 144Description: Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.
Measure: Duration of Objective Response for BV+ART vs. PTX+ART Time: From study entry up to week 144Description: SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) "pins and needles" in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade >=1 in at least one of the three assessments.
Measure: Number of Participants With Symptomatic Peripheral Neuropathy (SPN) Time: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.Description: Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes.
Measure: Number of Participants With Peripheral Neuropathy (PN) Time: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.Description: Adverse events classified by the site personnel as possibly, probably or definitely related to ART or chemotherapy.
Measure: Number of Participants With Treatment-related Toxicities and Adverse Events (AEs) Time: From study entry to week 240Description: Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.
Measure: Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART Time: Baseline, weeks 12, 24, 48Description: Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.
Measure: Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART Time: Baseline, weeks 12, 24, 48Description: ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses.
Measure: Self-reported Adherence to ART Therapy Time: At Weeks 6, 12, 18, 30 and 48Description: Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.
Measure: Presence of Oral KS Time: From study entry to week 240Description: Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.
Measure: Salivary KSHV Time: Baseline, weeks 60, 120, 180, 240Description: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: Quality of Life Measures Time: Baseline, weeks 60, 120, 180, 240Description: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: Immunohistochemical Evaluations of Viral and Cellular Gene Expression. Time: Baseline, 24-48 hours after 2nd chemo-therapy cycle beginsDescription: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: Plasma KS-associated Herpesvirus (KSHV) Time: Baseline, weeks 60, 120, 180, 240Description: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: Peripheral Blood Mononuclear Cell (PBMC) KSHV Time: Baseline, weeks 60, 120, 180, 240Description: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: RNA Levels for KSHV Genes Time: Baseline, weeks 60, 120, 180, 240Description: This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results are further delayed due to COVID-19 pandemic and will be reported to ct.gov when available.
Measure: Cellular and Humoral Markers of Immune Function and Activation Time: Baseline, weeks 60, 120, 180, 240Description: The number of participants with IERC-confirmed KS disease progression, dose-limiting toxicity, death, AIDS-defining events, virologic failure and objective response (complete response or partial response) as best overall KS response during Step 2. Results are presented by Step 2 treatment arm.
Measure: Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2 Time: From Step 2 study entry to Step 2 discontinuationDescription: The number of participants with IERC-confirmed KS disease progression, dose-limiting toxicity, death, AIDS-defining events, virologic failure and objective response (complete response or partial response) as best overall KS response during Step 3. Results are presented by Step 3 treatment arm.
Measure: Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3 Time: From Step 3 study entry to Step 3 discontinuationDescription: The number of participants with IERC-confirmed KS disease progression, dose-limiting toxicity, death, AIDS-defining events, virologic failure and objective response (complete response or partial response) as best overall KS response during Step 4. Results are presented by Step 4 treatment arm.
Measure: Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4 Time: From Step 4 study entry to Step 4 discontinuationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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