Trial · NCT01435018
Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS
NCT01435018, Phase 3, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS. Trials, record NCT01435018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01435018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS
- NCT number
- NCT01435018
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 334 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV-1 Infection
- Interventions
- Etoposide (ET), Bleomycin and Vincristine (BV), Paclitaxel (PTX), Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)
- First posted
- 2011-09-15
- Last updated
- 2021-10-20
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | 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). |
| Primary | Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | 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). |
| Secondary | Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | 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. |
| Secondary | Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | 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. |
| Secondary | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | 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). |
| Secondary | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | 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). |
| Secondary | Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | 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. |
| Secondary | Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | 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. |
| Secondary | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | 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. |
| Secondary | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | 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. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2016. | Cumulative events per 100 persons | NUMBER |
| PRIMARY | Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2018. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2016. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2018. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2016. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2018. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2016. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2018. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2016. | Cumulative events per 100 persons | NUMBER |
| SECONDARY | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART | From study entry to week 48 | All eligible participants who initiated study chemotherapy with available data as of March 2018. | Cumulative events per 100 persons | NUMBER |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group191
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART | ET+ART | 19.7 | 95% Confidence Interval 6.3 to 33.1 | Cumulative events per 100 persons | |
| Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART | PTX+ART | 49.8 | 95% Confidence Interval 32.4 to 67.3 | Cumulative events per 100 persons | |
| Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART | BV+ART | 44.1 | 95% Confidence Interval 35.0 to 53.2 | Cumulative events per 100 persons | |
| Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART | PTX+ART | 64.2 | 95% Confidence Interval 55.4 to 73.0 | Cumulative events per 100 persons | |
| Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART | ET+ART | 25.6 | 95% Confidence Interval 10.9 to 40.3 | Cumulative events per 100 persons | |
| Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART | PTX+ART | 10.7 | 95% Confidence Interval 2.6 to 18.8 | Cumulative events per 100 persons | |
| Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART | BV+ART | 18.5 | 95% Confidence Interval 11.5 to 25.5 | Cumulative events per 100 persons | |
| Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART | PTX+ART | 10.3 | 95% Confidence Interval 5.0 to 15.7 | Cumulative events per 100 persons | |
| Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART | ET+ART | 69.8 | 95% Confidence Interval 54.2 to 85.3 | Cumulative events per 100 persons | |
| Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART | PTX+ART | 41.2 | 95% Confidence Interval 21.8 to 60.7 | Cumulative events per 100 persons |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BV+ART | 135 | |
| Overall Study | STARTED | ET+ART | 60 | |
| Overall Study | STARTED | PTX+ART | 139 | |
| Overall Study | COMPLETED | BV+ART | 88 | |
| Overall Study | COMPLETED | ET+ART | 26 | |
| Overall Study | COMPLETED | PTX+ART | 98 | |
| Overall Study | NOT COMPLETED | BV+ART | 47 | |
| Overall Study | NOT COMPLETED | ET+ART | 34 | |
| Overall Study | NOT COMPLETED | PTX+ART | 41 |
Source ClinicalTrials.gov
Adverse events345
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 5 | 132 | |
| other | Anaemia | Blood and lymphatic system disorders | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 6 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 3 | 138 | |
| other | Abdominal pain | Gastrointestinal disorders | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 5 | 132 | |
| other | Abdominal pain | Gastrointestinal disorders | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 5 | 59 | |
| other | Abdominal pain | Gastrointestinal disorders | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 9 | 138 | |
| other | Diarrhoea | Gastrointestinal disorders | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 9 | 132 | |
| other | Diarrhoea | Gastrointestinal disorders | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 8 | 59 | |
| other | Diarrhoea | Gastrointestinal disorders | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 17 | 138 | |
| other | Gastritis | Gastrointestinal disorders | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 3 | 132 |
1 to 10 of 345Source ClinicalTrials.gov
See all 345 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 37 | 132 |
| Total, all-cause mortality | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 33 | 59 |
| Total, all-cause mortality | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 55 | 138 |
| Total, other adverse events | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 130 | 132 |
| Total, other adverse events | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 58 | 59 |
| Total, other adverse events | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 133 | 138 |
| Total, serious adverse events | Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF | 54 | 132 |
| Total, serious adverse events | Etoposide (ET) Plus Co-formulated EFV/FTC/TDF | 33 | 59 |
| Total, serious adverse events | Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF | 55 | 138 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01CA121947 | AIDS Malignancy Clinical Trials Consortium (AMC) | MITSUYASU, RONALD T. | UNIVERSITY OF CALIFORNIA LOS ANGELES | NATIONAL CANCER INSTITUTE | 2006 to 2014 | NIH RePORTER |
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 | NIH RePORTER |
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ET+ART vs PTX+ART: Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART | Trial comparisons |
| BV+ART vs PTX+ART: Number of Participants With Objective Response for BV+ART vs. PTX+ART | Trial comparisons |
| BV+ART vs PTX+ART: Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART | Trial comparisons |
| ET+ART vs PTX+ART: Number of Participants With Objective Response for ET+ART vs. PTX+ART | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01435018
GET https://conductscience.org/api/trials/v1/NCT01435018/registered?page=2