Three Chemo Regimens as an Adjunct to ART for Treatment o... | NCT01435018

NCT01435018

ID	Type	Description	Link
1U01AI068636	U.S. NIH Grant/Contract		View source
U01CA121947	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
National Cancer Institute (NCI)	NIH
National Institute of Dental and Craniofacial Research (NIDCR)	NIH

Oversight Module

Description Module

Detailed Description

The study consisted of four steps. Study duration was up to 240 weeks.

At the study Step 1 entry, participants were randomized with equal probability to each of the three regimens (ET+ART, BV+ART, PTX+ART). The original target sample size was 706. Randomization was stratified by:

Screening CD4 lymphocyte cell count (<100, >=100 cells/mm³), and
Country.

For participants who had an initial Independent Endpoint Review Committee (IERC) confirmed KS response and subsequent IERC-confirmed KS progression, and who, in the opinion of the investigator and with concurrence of the protocol Clinical Management Committee (CMC), could potentially have benefitted from another course of the same chemotherapy utilized in Step 1, entered Step 2. (Please see details on Step 2 eligibility.)

In Step 3, participants were randomized with equal probability to one of the two chemotherapy arms not utilized in Step 1. (Please see details on Step 3 eligibility.)

In Step 4, participants were assigned to the remaining study-provided chemotherapy not given in Step 1, Step 2 or Step 3. (Please see details on Step 4 eligibility.)

Step 1 visits occurred at screening, entry and weeks 3, 6, 9, 12, 15, 18, 21,24, 27, 30, 33, 36, 39, 42, 45, 48, 60, 72, 84 and 96 from study entry. Visits for Steps 2, 3 and 4 were scheduled at entry and weeks 3, 6, 9, 12, 15, 18, 21,24, 27, 30, 33, 36, 39, 42, 45, 48, 60, 72, 84 and 96 from the corresponding step entry date. Key evaluations included targeted physical examination, clinical assessment, KS examination, hematology, chemistry, pregnancy testing (for women of reproductive potential), and pulse oximetry for participants on BV+ART. CD4 count and HIV viral load were obtained every 12 weeks. Assessment of peripheral neuropathy was done at screening, weeks 9 and 21, and for those on BV+ART or PTX+ART, additionally at weeks 3, 6, 15 and 18. KS tumor punch biopsy, serum, plasma and peripheral blood mononuclear cells (PBMCs) were obtained and stored for use in future analyses. Participants also completed ET and ART adherence evaluations and quality of life questionnaires.

Enrollment to ET+ART and initiation of ET+ART in subsequent steps were discontinued in March 2016, based on the recommendation of the Data and Safety Monitoring Board (DSMB) due to ET+ART being less effective than PTX+ART. No safety concerns were identified. ET+ART participants in Step 1 or Step 2, in discussion with the local investigator and in consultation with the protocol CMC, could discontinue ET and enter Step 3. ET+ART participants in Step 3 could discontinue ET and start the remaining chemotherapy regimen in Step 4 in discussion with the local investigator and in consultation with the protocol CMC. Unless otherwise indicated, comparison between ET+ART and PTX+ART was based on the March 2016 data. The study remained open to enrollment and the remaining participants were randomized at Step 1 entry between BV+ART and PTX+ART. The target total sample size was revised to 446.

The DSMB recommended stopping the study in March 2018 due to BV+ART being inferior to PTX+ART. No safety concerns were identified. Study accrual was stopped. Eligible Step 1 PTX+ART participants entered Step 2 to receive PTX+ART; Step 1 and Step 2 BV+ART participants eligible to receive PTX+ART moved to Step 3 to receive PTX+ART. Otherwise, participants permanently transitioned to local care upon arrangement of appropriate oncology and ART, and then went off study. Participants who received ET while on study were followed for 144 weeks after beginning the last cycle of ET.

Comparison between BV+ART and PTX+ART was based on the March 2018 data.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ET+ART	Experimental	Etoposide (ET) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)	Drug: Etoposide (ET) Drug: Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)
BV+ART	Experimental	Bleomycin and Vincristine (BV) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)	Drug: Bleomycin and Vincristine (BV) Drug: Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)
PTX+ART	Active Comparator	Paclitaxel (PTX) plus co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)	Drug: Paclitaxel (PTX) Drug: Co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etoposide (ET)	Drug	Beginning on day one of the chemotherapy cycle, ET was given orally in a dose of 50 mg twice daily for 7 consecutive days for the first cycle. If there was no Grade >= 2 toxicity attributable to ET after the first cycle, the dose was escalated to 150 mg daily for 7 days in divided doses of 100 mg/50 mg for the second cycle. After the second cycle, if there was no Grade >= 2 toxicity attributable to ET, the dose was escalated to 100 mg twice daily for 7 days for the third and subsequent cycles. Treatment with ET was continued for six cycles at the maximum dose achieved or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the protocol CMC, had determined that alternative therapy is required, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART	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).	From study entry to week 48
Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART	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).	From study entry to week 48

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART	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.	From study entry to week 48

Other Outcomes

Measure	Description	Time Frame
Quality of Life Measures	The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to compare measures of quality of life in ET+ART, BV+ART and PTX+ART.

Eligibility Module

Eligibility Criteria

Inclusion Criteria for Step 1:

HIV-1 infection
Biopsy diagnostic of KS at any time prior to study entry.
Current KS stage T1 using ACTG criteria.
A minimum of five indicator KS cutaneous marker lesions (or if fewer than five marker lesions are available, the total surface area of the marker lesion(s) must be >=700 mm^2) plus an additional two lesions greater or equal to 4x4 mm that are accessible for punch biopsy.
CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS-approved laboratory.
Certain laboratory values, as defined in the protocol, obtained within 14 days prior to study entry.
Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of 15-25 mIU/mL performed within 48 hours before initiating the protocol-specified medications.
All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).
If participating in sexual activity that could lead to pregnancy, participant must agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for 12 weeks after stopping the medications. Study volunteers who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives.
Ability to swallow oral medications and adequate venous access.
Karnofsky performance status >= 60 within 28 days prior to entry.
Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria for Step 1:

Current chronic, acute, or recurrent serious infections for which the participant has not completed at least 14 days of therapy prior to study entry and/or is not clinically stable.
Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.
Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CT) scan.
Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days prior to study enrollment.
Grade >=3 peripheral neuropathy (PN) at entry.
Breastfeeding.
Receipt of ART for more than 42 days immediately prior to entry.
Prior or current systemic or locally administered chemotherapy.
Prior or current radiation therapy.
Prior or current immunotherapy, e.g., interferon alfa.
Corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.
Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational therapy or investigational vaccine within 30 days prior to study entry.
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
Active drug or alcohol use or dependence that would interfere with adherence to study requirements.
Current or anticipated receipt of any of the prohibited medications listed in section 5.5.2 of the protocol.
In the opinion of the investigator, any psychological or social condition, or addictive disorder that would preclude compliance with the protocol.

Inclusion Criteria for Step 2:

IERC-confirmed complete response (CR) or partial response (PR) to the chemotherapy regimen used in Step 1.
IERC-confirmed KS progression at least 12 weeks after the last dose of Step 1 chemotherapy.
Fewer than 72 weeks after Step 1 entry
Certain laboratory values, as defined in the protocol, obtained within 14 days prior to Step 2 entry.
For females of reproductive potential or females not of reproductive potential who do not have required documentation, negative serum or urine pregnancy test with a sensitivity of 15-25 mIU/mL within 7 days prior to Step 2 entry.
Karnofsky performance status >=50 within 28 days prior to Step 2
All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).

Exclusion Criteria Step 2:

Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable.
Severe toxicity to the chemotherapy regimen used in Step 1 requiring discontinuation of study chemotherapy.
Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 2 entry.
For volunteers who received bleomycin in Step 1
- Development of of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.
- Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 2 entry.
For volunteers who received Vincristine or Paclitaxel in Step 1, Grade >=3 PN at Step 2 entry.
Breastfeeding.
Other concurrent chemotherapy, immunotherapy, or radiotherapy.
Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 2 entry.
Receipt of Etoposide (ET) in Step 1.

Inclusion Criteria Step 3:

(a) IERC-confirmed KS progression at any time during Step 1 chemotherapy, or (b) IERC-confirmed KS progression fewer than 12 weeks after the last chemotherapy dose in Step 1 in participants who have had an IERC-confirmed CR or PR, or (c) IERC-confirmed KS progression following Step 1 chemotherapy, without any prior response, or (d) IERC-confirmed KS progression in Step 2, or (d) with concurrence of the CMC, there is dose-limiting toxicity after receiving fewer than four cycles of chemotherapy in Step 1 or Step 2, in the absence of a CR or PR, or (e) volunteers otherwise eligible for Step 2 who, in the opinion of the investigator and with concurrence of the CMC, are unlikely to benefit from another course of the same chemotherapy received in Step 1.
Fewer than 72 weeks after Step 1 entry.
Certain laboratory values, as defined in the protocol, obtained within 14 days prior to Step 3 entry.
For females of reproductive potential or females not of reproductive potential who do not have required documentation, negative serum or urine pregnancy test with a sensitivity of 15-25 mIU/mL within 7 days prior to Step 3 entry.
Karnofsky performance status >=50 within 28 days prior to Step 3 entry.
All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).

Exclusion Criteria Step 3:

Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 3 entry and/or is not clinically stable.
Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 3 entry.
Eligible for Step 2 entry.
For participants who did not receive bleomycin in Step 1 or Step 2:
- Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.
- Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 3 entry.
Grade >=3 PN at Step 3 entry.
Breastfeeding
Other concurrent chemotherapy, immunotherapy, or radiotherapy.
Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 3 entry.

Inclusion Criteria Step 4:

(a) IERC-confirmed KS progression in Step 3, or (b) With concurrence of the CMC, dose-limiting toxicity after receiving fewer than four cycles of chemotherapy in Step 3, in the absence of a CR or PR, or (c) Current receipt of ET in Step 3.
Fewer than 72 weeks after Step 1 entry.
Certain laboratory values, as defined in the protocol, obtained within 14 days prior to Step 4 entry.
For females of reproductive potential or females not of reproductive potential who do not have required documentation, negative serum or urine pregnancy test with a sensitivity of 15-25 mIU/mL within 7 days prior to Step 4 entry.
Karnofsky performance status >=50 within 28 days prior to Step 4 entry.
All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).
Receipt of ET in Step 1, Step 2, or Step 3.

Exclusion Criteria Step 4:

Current chronic, acute, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy prior to Step 4 entry and/or is not clinically stable.
Serious illness, other than progressive KS, requiring systemic treatment and/or hospitalization within 14 days prior to Step 4 entry.
For participants who did not receive bleomycin in Step 1, Step 2, or Step 3:
- Development of pulmonary fibrosis, COPD, emphysema, bronchiectasis, and diffuse or significant local radiographic interstitial infiltrates on CXR or CT scan that in the opinion of the site investigator would exclude bleomycin use.
- Oxygen saturation less than 90% or exercise desaturation greater than 4% within the last 30 days prior to Step 4 entry.
Grade >=3 PN at Step 4 entry.
Breastfeeding.
Other concurrent chemotherapy, immunotherapy, or radiotherapy.
Systemic corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within 30 days of Step 4 entry.

Contacts/Locations Module

Name	Affiliation	Role
Margaret Borok-Williams, MD	University of Zimbabwe	Study Chair
Susan E. Krown, MD	AIDS Malignancy Consortium	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Pesquisa Clinica Evandro Chagas (12101)		Rio de Janeiro		21045	Brazil
Moi University International Clnical Trials Unit

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2671281	Background	Krown SE, Metroka C, Wernz JC. Kaposi's sarcoma in the acquired immune deficiency syndrome: a proposal for uniform evaluation, response, and staging criteria. AIDS Clinical Trials Group Oncology Committee. J Clin Oncol. 1989 Sep;7(9):1201-7. doi: 10.1200/JCO.1989.7.9.1201.
11773164	Background	Cianfrocca M, Cooley TP, Lee JY, Rudek MA, Scadden DT, Ratner L, Pluda JM, Figg WD, Krown SE, Dezube BJ. Matrix metalloproteinase inhibitor COL-3 in the treatment of AIDS-related Kaposi's sarcoma: a phase I AIDS malignancy consortium study. J Clin Oncol. 2002 Jan 1;20(1):153-9. doi: 10.1200/JCO.2002.20.1.153.

Label	URL
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
FG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form	Jun 11, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

All randomized participants who were eligible for the study and who started their randomized chemotherapy.

Arm/Group Information

ID	Title	Description
BG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
BG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
BG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00035(18 to 64) BG00135(23 to 72) BG00235(20 to 65) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00031 BG00114 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Malawi

Title	Measurements
	BG00054 BG00127 BG002

CD4 Cell Count, categorized

CD4 cell count at screening.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<100 cells/mm^3	BG00026 BG00114 BG002

Karnofsky Performance Score

Karnofsky performance score at screening. Karnofsky performance score is from 0 (dead) to 100 (normal; no complaints; no evidence of disease) by increments of 10.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
60	BG0001 BG0011

CD4 Cell Count

Mean of screening and entry CD4 cell count

Median

Inter-Quartile Range

cells/mm^3

Title

Denominators

Categories

Title	Measurements
	BG000232(134 to 369) BG001216(99 to 357)

HIV-1 RNA, continuous

HIV-1 RNA at entry

Median

Inter-Quartile Range

Log10 copies/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.6(2.7 to 5.2) BG0014.9(3.9 to 5.3)

HIV-1 RNA, categorized

HIV-1 RNA at entry

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<400 copies/mL	BG00029 BG0014 BG002

Number of Cutaneous KS Lesions

At study entry

Count of Participants

Participants

Title

Denominators

Categories

<=50 lesions

Title	Measurements
	BG00032 BG00121 BG002

Presence of Oral Cavity KS Lesions

At study entry

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00090 BG00136 BG002

Presence of Lower Limb Edema

At study entry

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00071 BG00124 BG002

Presence of Lower Limb Edema in Both Limbs

At study entry

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00039 BG00111 BG002

Presence of Visceral KS

At study entry

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00036 BG00120 BG002

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

Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART

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).

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG00059 OG00159

Title

Denominators

Categories

Title	Measurements
	OG00019.7(6.3 to 33.1) OG00149.8(32.4 to 67.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.					Cumulative rate difference	-30.3			2-Sided	95	-52.3	-8.3			Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.		Non-Inferiority	Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the "maximum treatment difference that is considered clinically relevant" (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy).

Primary

Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Secondary

Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART

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).

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Count of Participants

Participants

From study entry to week 12

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

From study entry to week 12

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART

The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of Death for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 240

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Cumulative Rate of Death for BV+ART vs PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

Cumulative events per 100 persons

From study entry to week 240

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Number

95% Confidence Interval

weeks

From study entry to week 240

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Number

95% Confidence Interval

weeks

From study entry to week 240

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Number of Participants With Objective Response for ET+ART vs. PTX+ART

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).

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Count of Participants

Participants

From study entry up to week 144

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Number of Participants With Objective Response for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

From study entry up to week 144

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Duration of Objective Response for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2016.

Posted

Number

95% Confidence Interval

weeks

From study entry up to week 144

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Duration of Objective Response for BV+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2018.

Posted

Number

95% Confidence Interval

weeks

From study entry up to week 144

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Symptomatic Peripheral Neuropathy (SPN)

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Secondary

Number of Participants With Peripheral Neuropathy (PN)

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)

Adverse events classified by the site personnel as possibly, probably or definitely related to ART or chemotherapy.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

From study entry to week 240

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART

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.

All eligible participants who initiated study chemotherapy with available data as of March 2016.

Posted

Median

Inter-Quartile Range

cells/mm^3

Baseline, weeks 12, 24, 48

ID	Title	Description
OG000	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Median

Inter-Quartile Range

cells/mm^3

Baseline, weeks 12, 24, 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Self-reported Adherence to ART Therapy

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.

All eligible participants who initiated study chemotherapy with available data as of March 2018.

Posted

Count of Participants

Participants

At Weeks 6, 12, 18, 30 and 48

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants

Secondary

Presence of Oral KS

Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.

The corresponding outcome measure was withdrawn.

Posted

From study entry to week 240

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Salivary KSHV

Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.

The corresponding outcome measure was withdrawn.

Posted

Baseline, weeks 60, 120, 180, 240

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG002	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Units	Counts
Participants	OG000

Secondary

Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2

IERC-confirmed KS progression refers to 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). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). 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. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm.

All eligible participants who entered Step 2 with available data as of March 2018.

Posted

Count of Participants

Participants

From Step 2 study entry to Step 2 discontinuation, up to 144 weeks

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Secondary

Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3

All eligible participants who entered Step 3 with available data as of March 2018.

Posted

Count of Participants

Participants

From Step 3 study entry to Step 3 discontinuation, up to 144 weeks

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	ET+ART	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Secondary

Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4

All eligible participants who entered Step 4 with available data as of March 2018.

Posted

Count of Participants

Participants

From Step 4 study entry to Step 4 discontinuation, up to 96 weeks

ID	Title	Description
OG000	BV+ART	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)
OG001	PTX+ART	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)

Other Pre-specified

Quality of Life Measures

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to compare measures of quality of life in ET+ART, BV+ART and PTX+ART.

Not Posted

Baseline, weeks 60, 120, 180, 240

Participants

Other Pre-specified

Immunohistochemical Evaluations of Viral and Cellular Gene Expression

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with immunohistochemical markers of viral and cellular gene expression in KS tumors. The laboratory assays for this outcome measure have not been completed.

Not Posted

Baseline, 24-48 hours after 2nd chemo-therapy cycle begins

Participants

Other Pre-specified

RNA Levels for KSHV Genes

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with RNA levels for KSHV genes in tumor biopsies. The laboratory assays for this outcome measure have not been completed.

Not Posted

Baseline, weeks 60, 120, 180, 240

Participants

Other Pre-specified

Cellular and Humoral Markers of Immune Function and Activation

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to evaluate the relationship between response of KS to therapy and development of KS-IRIS with cellular and humoral markers of immune function and activation. The laboratory assays for this outcome measure have not been completed.

Not Posted

Baseline, weeks 60, 120, 180, 240

Participants

Other Pre-specified

Plasma KS-associated Herpesvirus (KSHV)

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to investigate the relationship between plasma and PBMC KSHV viral load. The laboratory assays for this outcome measure have not been completed.

Not Posted

Baseline, weeks 60, 120, 180, 240

Participants

Other Pre-specified

Peripheral Blood Mononuclear Cell (PBMC) KSHV

The protocol did not distinguish between outcome measures essential to the primary publication and those of lesser importance and priority which are not the focus of the study but intended for subsequent publications of exploratory analyses, conditional on primary results and additional funding. This outcome measure was listed under secondary outcome measures in the study protocol but was intended for an exploratory analysis to investigate the relationship between plasma and PBMC KSHV viral load. The laboratory assays for this outcome measure have not been completed.

Not Posted

Baseline, weeks 60, 120, 180, 240

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bleomycin Plus Vincristine (BV) Plus Co-formulated EFV/FTC/TDF	Bleomycin and Vincristine plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)	37	132	54	132	130	132
EG001	Etoposide (ET) Plus Co-formulated EFV/FTC/TDF	Etoposide plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)	33	59	33	59	58	59
EG002	Paclitaxel (PTX) Plus Co-formulated EFV/FTC/TDF	Paclitaxel plus ART (co-formulated Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate)	55	138	55	138	133	138

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected132 at risk EG0012 affected59 at risk EG0028 affected138 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0016 affected59 at risk EG0024 affected138 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0021 affected138 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 affected132 at risk EG0012 affected59 at risk EG0025 affected138 at risk
Drowning	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Bacterial infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Bacterial sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0014 affected59 at risk EG0026 affected138 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Central nervous system infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Chronic hepatitis B	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0021 affected138 at risk
Encephalitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Extrapulmonary tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected59 at risk EG0020 affected138 at risk
Gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected59 at risk EG0022 affected138 at risk
HIV infection WHO clinical stage IV	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Immune reconstitution inflammatory syndrome associated tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Malaria	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Meningitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Osteomyelitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected132 at risk EG0012 affected59 at risk EG0026 affected138 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 affected132 at risk EG0012 affected59 at risk EG0023 affected138 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0021 affected138 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Urosepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0012 affected59 at risk EG0023 affected138 at risk
Blood bicarbonate decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected59 at risk EG0020 affected138 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected59 at risk EG0020 affected138 at risk
Blood sodium decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Haemoglobin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Hepatic enzyme increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Transaminases increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected59 at risk EG0021 affected138 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0012 affected59 at risk EG0021 affected138 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG00013 affected132 at risk EG00110 affected59 at risk EG0029 affected138 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Abortion complete	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Completed suicide	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0021 affected138 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0020 affected138 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0016 affected59 at risk EG0023 affected138 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0015 affected59 at risk EG0029 affected138 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected132 at risk EG0018 affected59 at risk EG00217 affected138 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0013 affected59 at risk EG0021 affected138 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected132 at risk EG0019 affected59 at risk EG00213 affected138 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 affected132 at risk EG0012 affected59 at risk EG0024 affected138 at risk
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected132 at risk EG0015 affected59 at risk EG00213 affected138 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0013 affected59 at risk EG0024 affected138 at risk
Mucosal discolouration	General disorders	MedDRA 23.0	Systematic Assessment	EG0009 affected132 at risk EG0014 affected59 at risk EG0021 affected138 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00017 affected132 at risk EG0013 affected59 at risk EG00213 affected138 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected132 at risk EG0015 affected59 at risk EG0026 affected138 at risk
Peripheral swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0015 affected59 at risk EG0025 affected138 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00026 affected132 at risk EG00114 affected59 at risk EG00222 affected138 at risk
Bacterial sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00012 affected132 at risk EG0015 affected59 at risk EG0025 affected138 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0014 affected59 at risk EG0021 affected138 at risk
Malaria	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 affected132 at risk EG0012 affected59 at risk EG0025 affected138 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 affected132 at risk EG0013 affected59 at risk EG00213 affected138 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 affected132 at risk EG0014 affected59 at risk EG0023 affected138 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0016 affected59 at risk EG0027 affected138 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0015 affected59 at risk EG0023 affected138 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00014 affected132 at risk EG0015 affected59 at risk EG00216 affected138 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00020 affected132 at risk EG00115 affected59 at risk EG00229 affected138 at risk
Blood albumin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00084 affected132 at risk EG00140 affected59 at risk EG00286 affected138 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00023 affected132 at risk EG0019 affected59 at risk EG00223 affected138 at risk
Blood bicarbonate decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00021 affected132 at risk EG0019 affected59 at risk EG00222 affected138 at risk
Blood bilirubin increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0007 affected132 at risk EG0014 affected59 at risk EG0025 affected138 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00014 affected132 at risk EG0019 affected59 at risk EG00213 affected138 at risk
Blood glucose decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0008 affected132 at risk EG0014 affected59 at risk EG0026 affected138 at risk
Blood glucose increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00020 affected132 at risk EG00111 affected59 at risk EG00224 affected138 at risk
Blood phosphorus decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00018 affected132 at risk EG0019 affected59 at risk EG00226 affected138 at risk
Blood potassium increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0013 affected59 at risk EG0021 affected138 at risk
Blood sodium decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00058 affected132 at risk EG00131 affected59 at risk EG00262 affected138 at risk
Carbon dioxide decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0008 affected132 at risk EG0019 affected59 at risk EG0023 affected138 at risk
Haemoglobin decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00047 affected132 at risk EG00129 affected59 at risk EG00248 affected138 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00042 affected132 at risk EG00129 affected59 at risk EG00255 affected138 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00027 affected132 at risk EG00110 affected59 at risk EG00221 affected138 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00023 affected132 at risk EG00110 affected59 at risk EG00217 affected138 at risk
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0016 affected59 at risk EG00213 affected138 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected132 at risk EG0014 affected59 at risk EG0029 affected138 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00025 affected132 at risk EG00111 affected59 at risk EG00217 affected138 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG00010 affected132 at risk EG0018 affected59 at risk EG00211 affected138 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected132 at risk EG0017 affected59 at risk EG0026 affected138 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected59 at risk EG0027 affected138 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0015 affected59 at risk EG0023 affected138 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0013 affected59 at risk EG0024 affected138 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00019 affected132 at risk EG00113 affected59 at risk EG00227 affected138 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 affected132 at risk EG0018 affected59 at risk EG00210 affected138 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected132 at risk EG0011 affected59 at risk EG0027 affected138 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0013 affected59 at risk EG0027 affected138 at risk

ID	Term
D005047	Etoposide
D001761	Bleomycin
D014750	Vincristine
D017239	Paclitaxel
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Ancestor Terms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D006020	Glycopeptides
D006001	Glycoconjugates
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D004224	Diterpenes
D013729	Terpenes
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D000225	Adenine
D011687	Purines
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

BG003229(120 to 357)

BG0034.4(2.7 to 5.2)

OG000132
OG00159
OG002138

OG000132
OG00159
OG002138