Trial · NCT01352117
Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma
NCT01352117, Phase 3, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2017-07-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma. Trials, record NCT01352117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01352117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma
- NCT number
- NCT01352117
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 192 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV-1 Infection, Kaposi's Sarcoma
- Interventions
- efavirenz/emtricitabine/tenofovir disoproxil fumarate, etoposide
- First posted
- 2011-05-11
- Last updated
- 2019-11-14
- Results first posted
- 2017-07-31
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Entry through Week 48. | KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on 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). Data on initiation of alternate KS treatment, loss to follow-up and dea |
| Secondary | KS Progressive Disease at Week 48 Compared to Study Entry | Entry and Week 48 | KS progressive disease (PD) compared to study entry based on 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 | KS Partial Response at Week 48 Compared to Study Entry | Entry and Week 48 | KS partial response (PR) compared to study entry based on 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 | KS Complete Response at Week 48 Compared to Study Entry | Entry and Week 48 | KS complete response (CR) compared to study entry based on 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 | KS Partial or Complete Response at Week 48 Compared to Study Entry | Entry and Week 48 | KS partial response (PR) or complete response (CR) compared to study entry based on 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 | Premature Study Discontinuation by Week 48 | Entry through Week 48 | Premature study discontinuation by Week 48 due to any reason, including death. |
| Secondary | Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry | Entry through Week 96. | KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on 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). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96. |
| Secondary | KS Progressive Disease at Week 96 Compared to Study Entry | Entry and Week 96 | KS progressive disease (PD) compared to study entry based on 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 | KS Partial Response at Week 96 Compared to Study Entry | Entry and Week 96 | KS partial response (PR) compared to study entry based on 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 | KS Complete Response at Week 96 Compared to Study Entry | Entry and Week 96 | KS complete response (CR) compared to study entry based on 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). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Entry through Week 48. | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's \[DSMB\] recommendation to close the study became public). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Progressive Disease at Week 48 Compared to Study Entry | Entry and Week 48 | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Partial Response at Week 48 Compared to Study Entry | Entry and Week 48 | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Complete Response at Week 48 Compared to Study Entry | Entry and Week 48 | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Partial or Complete Response at Week 48 Compared to Study Entry | Entry and Week 48 | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Premature Study Discontinuation by Week 48 | Entry through Week 48 | All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry | Entry through Week 96. | All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Progressive Disease at Week 96 Compared to Study Entry | Entry and Week 96 | All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Partial Response at Week 96 Compared to Study Entry | Entry and Week 96 | All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | KS Complete Response at Week 96 Compared to Study Entry | Entry and Week 96 | All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm A: ART Alone or With Delayed ET | E1 (Failure) | 43 | Participants | |
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm B: ART With Immediate ET | E1 (Failure) | 47 | Participants | |
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm A: ART Alone or With Delayed ET | E2 (Stable) | 13 | Participants | |
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm B: ART With Immediate ET | E2 (Stable) | 9 | Participants | |
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm A: ART Alone or With Delayed ET | E3 (Response) | 24 | Participants | |
| Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry | Arm B: ART With Immediate ET | E3 (Response) | 27 | Participants | |
| KS Progressive Disease at Week 48 Compared to Study Entry | Arm A: ART Alone or With Delayed ET | KS PD at Week 48 | 21 | Participants | |
| KS Progressive Disease at Week 48 Compared to Study Entry | Arm B: ART With Immediate ET | KS PD at Week 48 | 7 | Participants | |
| KS Progressive Disease at Week 48 Compared to Study Entry | Arm A: ART Alone or With Delayed ET | No KS PD at Week 48 | 37 | Participants | |
| KS Progressive Disease at Week 48 Compared to Study Entry | Arm B: ART With Immediate ET | No KS PD at Week 48 | 36 | Participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: ART Alone or With Delayed ET | 96 | |
| Overall Study | STARTED | Arm B: ART With Immediate ET | 96 | |
| Overall Study | Entered Step 2 to Initiate Delayed ET | Arm A: ART Alone or With Delayed ET | 32 | |
| Overall Study | Entered Step 2 to Initiate Delayed ET | Arm B: ART With Immediate ET | 0 | |
| Overall Study | Study Week 48 Data Potential | Arm A: ART Alone or With Delayed ET | 80 | |
| Overall Study | Study Week 48 Data Potential | Arm B: ART With Immediate ET | 83 | |
| Overall Study | Study Week 96 Data Potential | Arm A: ART Alone or With Delayed ET | 58 | |
| Overall Study | Study Week 96 Data Potential | Arm B: ART With Immediate ET | 61 | |
| Overall Study | COMPLETED | Arm A: ART Alone or With Delayed ET | 75 | |
| Overall Study | COMPLETED | Arm B: ART With Immediate ET | 72 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events192
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 | Arm A: ART Alone or With Delayed ET | 7 | 94 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: ART With Immediate ET | 5 | 96 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm A: ART Alone or With Delayed ET | 6 | 94 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm B: ART With Immediate ET | 4 | 96 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: ART Alone or With Delayed ET | 6 | 94 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: ART With Immediate ET | 8 | 96 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Arm A: ART Alone or With Delayed ET | 0 | 94 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Arm B: ART With Immediate ET | 6 | 96 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm A: ART Alone or With Delayed ET | 8 | 94 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm B: ART With Immediate ET | 11 | 96 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: ART Alone or With Delayed ET | 15 | 94 |
| Total, all-cause mortality | Arm B: ART With Immediate ET | 16 | 96 |
| Total, other adverse events | Arm A: ART Alone or With Delayed ET | 83 | 94 |
| Total, other adverse events | Arm B: ART With Immediate ET | 88 | 96 |
| Total, serious adverse events | Arm A: ART Alone or With Delayed ET | 34 | 94 |
| Total, serious adverse events | Arm B: ART With Immediate ET | 34 | 96 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: ART Alone or With Delayed ET vs Arm B: ART With Immediate ET: Number of Participants With Grade 3 or Higher Adverse Events | Trial comparisons |
| Arm A: ART Alone or With Delayed ET vs Arm B: ART With Immediate ET: deaths from any cause | Trial comparisons |
| Arm A: ART Alone or With Delayed ET vs Arm B: ART With Immediate ET: serious adverse events | 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/NCT01352117
GET https://conductscience.org/api/trials/v1/NCT01352117/registered?page=2