Trial Outcomes & Findings for Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings (NCT NCT00084136)

Last Updated: 2018-10-10

Results Overview

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1571 participants

Primary outcome timeframe

Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).

Results posted on

2018-10-10

Participant Flow

Study participants were recruited at 43 sites from 9 countries: 28 in the US, 4 in India, 2 each in Brazil, Malawi, Peru and South Africa, and 1 each in Haiti, Thailand and Zimbabwe, between May 2005 to August 2007.

HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count \<300 cells/mm\^3.

Participant milestones

Participant milestones
Measure	ZDV/3TC+EFV ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine \> \> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed.	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
PI Comparison STARTED	519	526	0
PI Comparison COMPLETED	464	479	0
PI Comparison NOT COMPLETED	55	47	0
NRTI Comparison STARTED	519	0	526
NRTI Comparison COMPLETED	418	0	444
NRTI Comparison NOT COMPLETED	101	0	82

Reasons for withdrawal

Reasons for withdrawal
Measure	ZDV/3TC+EFV ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine \> \> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed.	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
PI Comparison Death	10	9	0
PI Comparison Lost to Follow-up	11	8	0
PI Comparison Withdrawal by Subject	33	30	0
PI Comparison Clinic site closed	1	0	0
NRTI Comparison Death	20	0	18
NRTI Comparison Lost to Follow-up	14	0	12
NRTI Comparison Withdrawal by Subject	54	0	38
NRTI Comparison Clinic site closed	12	0	14
NRTI Comparison Not reason above	1	0	0

Baseline Characteristics

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine \> \> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed.	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz	Total n=1571 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 9 • n=5 Participants	35 years STANDARD_DEVIATION 8 • n=7 Participants	35 years STANDARD_DEVIATION 9 • n=5 Participants	35 years STANDARD_DEVIATION 9 • n=4 Participants
Age, Customized Between 18 and 29 years	141 participants n=5 Participants	146 participants n=7 Participants	146 participants n=5 Participants	433 participants n=4 Participants
Age, Customized Between 30 and 39 years	244 participants n=5 Participants	221 participants n=7 Participants	225 participants n=5 Participants	690 participants n=4 Participants
Age, Customized Between 40 and 49 years	100 participants n=5 Participants	129 participants n=7 Participants	116 participants n=5 Participants	345 participants n=4 Participants
Age, Customized At least 50 years	34 participants n=5 Participants	30 participants n=7 Participants	39 participants n=5 Participants	103 participants n=4 Participants
Sex: Female, Male Female	241 Participants n=5 Participants	256 Participants n=7 Participants	242 Participants n=5 Participants	739 Participants n=4 Participants
Sex: Female, Male Male	278 Participants n=5 Participants	270 Participants n=7 Participants	284 Participants n=5 Participants	832 Participants n=4 Participants
Region of Enrollment Brazil	79 participants n=5 Participants	76 participants n=7 Participants	76 participants n=5 Participants	231 participants n=4 Participants
Region of Enrollment Haiti	35 participants n=5 Participants	32 participants n=7 Participants	33 participants n=5 Participants	100 participants n=4 Participants
Region of Enrollment India	81 participants n=5 Participants	86 participants n=7 Participants	88 participants n=5 Participants	255 participants n=4 Participants
Region of Enrollment Malawi	74 participants n=5 Participants	74 participants n=7 Participants	73 participants n=5 Participants	221 participants n=4 Participants
Region of Enrollment Peru	42 participants n=5 Participants	48 participants n=7 Participants	44 participants n=5 Participants	134 participants n=4 Participants
Region of Enrollment South Africa	70 participants n=5 Participants	70 participants n=7 Participants	70 participants n=5 Participants	210 participants n=4 Participants
Region of Enrollment Thailand	32 participants n=5 Participants	33 participants n=7 Participants	35 participants n=5 Participants	100 participants n=4 Participants
Region of Enrollment United States	70 participants n=5 Participants	70 participants n=7 Participants	70 participants n=5 Participants	210 participants n=4 Participants
Region of Enrollment Zimbabwe	36 participants n=5 Participants	37 participants n=7 Participants	37 participants n=5 Participants	110 participants n=4 Participants
CD4 count, Continuous	163 cells/mm^3 STANDARD_DEVIATION 85 • n=5 Participants	167 cells/mm^3 STANDARD_DEVIATION 83 • n=7 Participants	155 cells/mm^3 STANDARD_DEVIATION 81 • n=5 Participants	162 cells/mm^3 STANDARD_DEVIATION 83 • n=4 Participants
CD4 count, Categorical < 50 cells/mm^3	68 participants n=5 Participants	63 participants n=7 Participants	69 participants n=5 Participants	200 participants n=4 Participants
CD4 count, Categorical Between 50 and 99 cells/mm^3	70 participants n=5 Participants	77 participants n=7 Participants	82 participants n=5 Participants	229 participants n=4 Participants
CD4 count, Categorical Between 100 and 199 cells/mm^3	174 participants n=5 Participants	161 participants n=7 Participants	193 participants n=5 Participants	528 participants n=4 Participants
CD4 count, Categorical Between 200 and 249 cells/mm^3	104 participants n=5 Participants	128 participants n=7 Participants	107 participants n=5 Participants	339 participants n=4 Participants
CD4 count, Categorical Between 250 and 299 cells/mm^3	103 participants n=5 Participants	97 participants n=7 Participants	75 participants n=5 Participants	275 participants n=4 Participants
Plasma HIV-1 RNA, Continuous	5.0 log10 copies/mL n=5 Participants	5.1 log10 copies/mL n=7 Participants	5.0 log10 copies/mL n=5 Participants	5.0 log10 copies/mL n=4 Participants
Plasma HIV-1 RNA, Categorical <= 400 copies/mL	3 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	12 participants n=4 Participants
Plasma HIV-1 RNA, Categorical Between 400 and 4000 copies/mL	22 participants n=5 Participants	19 participants n=7 Participants	14 participants n=5 Participants	55 participants n=4 Participants
Plasma HIV-1 RNA, Categorical Between 4001 and 40,000 copies/mL	103 participants n=5 Participants	119 participants n=7 Participants	124 participants n=5 Participants	346 participants n=4 Participants
Plasma HIV-1 RNA, Categorical Between 40,001 and 400,000 copies/mL	311 participants n=5 Participants	283 participants n=7 Participants	284 participants n=5 Participants	878 participants n=4 Participants
Plasma HIV-1 RNA, Categorical Between 400,001 and 749,999 copies/mL	45 participants n=5 Participants	58 participants n=7 Participants	55 participants n=5 Participants	158 participants n=4 Participants
Plasma HIV-1 RNA, Categorical >= 750,000 copies/mL	35 participants n=5 Participants	40 participants n=7 Participants	46 participants n=5 Participants	121 participants n=4 Participants
Plasma HIV-1 RNA, Categorical Missing	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).

Population: ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Treatment Failure (PI Comparison) 5th percentile	16 weeks Interval 16.0 to 24.0	16 weeks Interval 16.0 to 16.0	—
Time to Treatment Failure (PI Comparison) 10th percentile	40 weeks Interval 24.0 to 64.0	24 weeks Interval 16.0 to 32.0	—
Time to Treatment Failure (PI Comparison) 25th percentile	NA weeks Interval 152.0 to Not estimable as the estimate for survival function at all weeks is above 75%	120 weeks Interval 96.0 to Not estimable as the upper limit for survival function at all weeks is above 75%	—

PRIMARY outcome

Population: ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.

Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Treatment Failure (NRTI Comparison) 5th percentile	16 weeks Interval 16.0 to 24.0	—	16 weeks Interval 16.0 to 24.0
Time to Treatment Failure (NRTI Comparison) 10th percentile	40 weeks Interval 24.0 to 71.0	—	40 weeks Interval 24.0 to 64.0
Time to Treatment Failure (NRTI Comparison) 25th percentile	NA weeks Interval 224.0 to Not estimable as the estimate for survival function at all weeks is above 75%	—	NA weeks Interval 216.0 to Not estimable as the estimate for survival function at all weeks is above 75%

SECONDARY outcome

Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)

Population: Participants not starting study treatment excluded.

Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=518 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=522 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) 5th percentile	16 weeks Interval 8.0 to 22.0	7 weeks Interval 3.0 to 11.0	—
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) 10th percentile	34 weeks Interval 24.0 to 46.0	18 weeks Interval 12.0 to 23.0	—
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) 25th percentile	NA weeks Not estimable as the estimates for survival function at all weeks is above 75%	76 weeks Interval 50.0 to Not estimable as the upper limit for survival function at all weeks is above 75%	—

SECONDARY outcome

Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)

Population: ITT (ignoring current study treatment status or history)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Immunologic Failure (PI Comparison) 1st percentile	48 weeks Interval 48.0 to 48.0	48 weeks Interval 48.0 to 48.0	—
Time to Immunologic Failure (PI Comparison) 5th percentile	112 weeks Interval 48.0 to Not estimable as the upper limit for survival function at all weeks is above 5%	NA weeks Interval 64.0 to Not estimable as the estimate for survival function at all weeks is above 5%	—

SECONDARY outcome

Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

Population: ITT - ignoring both current treatment status and treatment history.

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) Change from screening to week 24 (N=490; N=502)	112.5 cells/mm^3 Interval 57.0 to 185.0	146.5 cells/mm^3 Interval 79.0 to 224.0	—
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) Change from screening to week 48 (N=474; N=477)	152.0 cells/mm^3 Interval 84.0 to 236.0	187.0 cells/mm^3 Interval 111.0 to 272.0	—
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) Change from screening to week 96 (N= 188; N=188)	216.0 cells/mm^3 Interval 149.0 to 300.5	256.0 cells/mm^3 Interval 142.5 to 371.0	—

SECONDARY outcome

Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)

Population: Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.

Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=518 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=522 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) 10th percentile	4 weeks Interval 4.0 to 4.0	4 weeks Interval 4.0 to 8.0	—
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) 25th percentile	12 weeks Interval 12.0 to 16.0	32 weeks Interval 20.0 to 40.0	—
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) 50th percentile	96 weeks Interval 72.0 to 144.0	144 weeks Interval 120.0 to Not estimable as the upper limit for survival function at all weeks is above 50%	—

SECONDARY outcome

Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)

Population: ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.

Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) Week 48: Number with RNA <400 c/mL (N=476; N=478)	437 participants	424 participants	—
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) Week 24: Number with RNA <400 c/mL (N=495; N=506)	459 participants	431 participants	—

SECONDARY outcome

Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	0 weeks Interval 0.0 to 0.0	—
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) 10th percentile	16 weeks Interval 8.0 to 32.0	0 weeks Interval 0.0 to 0.0	—
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) 25th percentile	NA weeks Not estimable as the estimates for survival function at all weeks is above 75%	48 weeks Interval 32.0 to Not estimable as the upper limit for survival function at all weeks is above 75%	—

SECONDARY outcome

Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)

Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV n=526 Participants ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	0 weeks Interval 0.0 to 0.0	—
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) 25th percentile	32 weeks Interval 16.0 to 48.0	48 weeks Interval 32.0 to Not estimable as the upper limit for survival function at all weeks is above 75%	—
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) 10th percentile	0 weeks Interval 0.0 to 0.0	0 weeks Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Throughout follow-up until study closed (May 31,2010)

Population: Participants not starting study treatment excluded.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=518 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=525 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) 5th percentile	16 weeks Interval 8.0 to 23.0	—	18 weeks Interval 8.0 to 24.0
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) 10th percentile	34 weeks Interval 24.0 to 45.0	—	36 weeks Interval 24.0 to 48.0
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) 25th percentile	163 weeks Interval 120.0 to 200.0	—	201 weeks Interval 160.0 to Not estimable as the upper limit for survival function at all weeks is above 75%

SECONDARY outcome

Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)

Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Immunologic Failure (NRTI Comparison) 1st percentile	48 weeks Interval 48.0 to 48.0	—	48 weeks Interval 48.0 to 48.0
Time to Immunologic Failure (NRTI Comparison) 10th percentile	NA weeks Interval 248.0 to Not estimable as the estimates for survival function at all weeks is above 90%	—	NA weeks Not estimable as all estimates for survival function at all weeks is above 90%
Time to Immunologic Failure (NRTI Comparison) 5th percentile	128 weeks Interval 48.0 to Not estimable as the upper limit for survival function at all weeks is above 95%	—	104 weeks Interval 48.0 to Not estimable as the upper limit for survival function at all weeks is above 95%

SECONDARY outcome

Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)

Population: ITT - ignoring both current treatment status and treatment history.

Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) Change from screening to week 24 (N=490; N=498)	112.5 cells/mm^3 Interval 57.0 to 185.0	—	120.5 cells/mm^3 Interval 67.0 to 181.0
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) Change from screening to week 48 (N=480; N=485)	151.5 cells/mm^3 Interval 84.0 to 233.5	—	159 cells/mm^3 Interval 97.0 to 237.0
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) Change from screening to week 96 (N=458; N=471)	220.5 cells/mm^3 Interval 143.0 to 313.0	—	226 cells/mm^3 Interval 142.0 to 321.0

SECONDARY outcome

Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)

Population: ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) Week 24: Number with RNA <400 c/mL (N=495; N=500)	459 participants	—	448 participants
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) Week 48: Number with RNA <400 c/mL (N=482; N=487)	442 participants	—	455 participants

SECONDARY outcome

Timeframe: Week 48 (using follow-up through study closure on May 31,2010)

Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 0.0
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 10th percentile	16 weeks Interval 0.0 to 32.0	—	24 weeks Interval 0.0 to 32.0

SECONDARY outcome

Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)

Population: Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 0.0
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 25th percentile	NA weeks Interval 88.0 to Not estimable as the estimates for survival function at all weeks is above 75%	—	NA weeks Not estimable as all estimates for survival function at all weeks is above 75%
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 10th percentile	16 weeks Interval 0.0 to 32.0	—	24 weeks Interval 0.0 to 32.0

SECONDARY outcome

Timeframe: Week 48 using follow-up through study closure on May 31,2010

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 10th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 24.0
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 0.0
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 25th percentile	32 weeks Interval 16.0 to 48.0	—	NA weeks Not estimable as all estimates for survival function at all weeks is above 75%

SECONDARY outcome

Timeframe: Week 96 using follow-up through study closure on May 31,2010

Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values \< 400 copies/mL; two consecutive plasma HIV-1 RNA values \> 400 copies/mL following virologic suppression.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=519 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=526 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 5th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 0.0
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 10th percentile	0 weeks Interval 0.0 to 0.0	—	0 weeks Interval 0.0 to 24.0
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 25th percentile	32 weeks Interval 16.0 to 56.0	—	NA weeks Interval 80.0 to Not estimable as the estimates for survival function at all weeks is above 75%

SECONDARY outcome

Timeframe: Throughout study follow-up until study closure (May 31, 2010)

Population: Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.

Outcome measures

Outcome measures
Measure	ZDV/3TC+EFV n=518 Participants ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz	ddI+FTC+ATV ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine	TDF/FTC+EFV n=525 Participants TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) 10th percentile	4 weeks Interval 4.0 to 4.0	—	4 weeks Interval 4.0 to 8.0
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) 25th percentile	12 weeks Interval 12.0 to 16.0	—	32 weeks Interval 24.0 to 48.0
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) 50th percentile	112 weeks Interval 72.0 to 136.0	—	224 weeks Interval 192.0 to Not estimable as the upper limit for survival function at all weeks is above 50%

Adverse Events

ZDV/3TC+EFV

Serious events: 86 serious events

Other events: 481 other events

Deaths: 0 deaths

ddI+FTC+ATV

Serious events: 84 serious events

Other events: 521 other events

Deaths: 0 deaths

TDF/FTC+EFV

Serious events: 55 serious events

Other events: 489 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

ACTG ClinicalTrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301) 628-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	ZDV/3TC+EFV n=519 participants at risk	ddI+FTC+ATV n=526 participants at risk	TDF/FTC+EFV n=526 participants at risk
Gastrointestinal disorders Vomiting	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Anaemia	2.3% 12/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Bone marrow failure	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Bone marrow toxicity	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Neutropenia	3.3% 17/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	1.5% 8/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Blood and lymphatic system disorders Thrombocytopenia	0.39% 2/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Acute coronary syndrome	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Angina pectoris	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Arrhythmia	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Cardiac failure congestive	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Hypertrophic cardiomyopathy	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Cardiac disorders Myocardial infarction	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Ear and labyrinth disorders Vertigo	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Abdominal pain	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Ascites	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Diarrhoea	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Oesophageal ulcer	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Pancreatitis	0.39% 2/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.95% 5/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Pancreatitis acute	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Pancreatitis chronic	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Peritonitis	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Death	0.77% 4/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Pyrexia	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Sudden death	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Hepatitis	0.77% 4/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.95% 5/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Hepatotoxicity	0.39% 2/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Hyperbilirubinaemia	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	1.5% 8/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Jaundice cholestatic	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Immune system disorders Drug hypersensitivity	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Immune system disorders Hypersensitivity	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations AIDS related complex	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Abortion infected	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Bronchopneumonia	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Chikungunya virus infection	0.19% 1/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Corynebacterium sepsis	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Cryptococcosis	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.00% 0/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Disseminated tuberculosis	0.00% 0/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.19% 1/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	0.38% 2/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.

Other adverse events
Measure	ZDV/3TC+EFV n=519 participants at risk	ddI+FTC+ATV n=526 participants at risk	TDF/FTC+EFV n=526 participants at risk
Blood and lymphatic system disorders Lymphadenopathy	5.2% 27/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.6% 24/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.7% 30/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Eye disorders Ocular icterus	1.3% 7/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.3% 49/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	2.3% 12/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Abdominal pain	7.5% 39/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	10.8% 57/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.9% 52/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Diarrhoea	8.3% 43/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.7% 46/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	12.0% 63/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Nausea	9.2% 48/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.4% 44/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.8% 36/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Gastrointestinal disorders Vomiting	11.6% 60/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.9% 47/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.5% 50/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Chest pain	6.6% 34/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.0% 37/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.3% 28/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Pain	6.9% 36/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.2% 43/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.0% 42/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
General disorders Pyrexia	18.5% 96/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	22.8% 120/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	21.3% 112/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Hepatobiliary disorders Hyperbilirubinaemia	0.77% 4/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.5% 34/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	1.1% 6/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Herpes zoster	7.3% 38/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.8% 41/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.3% 33/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Malaria	8.3% 43/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.4% 44/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.6% 40/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Oral candidiasis	4.6% 24/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.4% 23/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.1% 27/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Pharyngitis	3.7% 19/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	3.8% 20/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.3% 28/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Pneumonia bacterial	5.4% 28/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.7% 30/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.3% 28/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Infections and infestations Upper respiratory tract infection	7.1% 37/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.0% 37/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	8.6% 45/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Alanine aminotransferase increased	42.4% 220/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	49.6% 261/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	50.4% 265/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Aspartate aminotransferase increased	51.8% 269/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	57.8% 304/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	54.9% 289/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood albumin abnormal	33.5% 174/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	35.7% 188/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	35.7% 188/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood alkaline phosphatase increased	3.5% 18/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.0% 37/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.6% 24/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood bicarbonate abnormal	6.7% 35/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	11.4% 60/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.1% 48/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood bilirubin increased	8.5% 44/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	75.5% 397/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.4% 39/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood phosphorus decreased	14.5% 75/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	16.5% 87/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	15.2% 80/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood potassium decreased	5.8% 30/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.5% 29/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.4% 39/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Blood sodium decreased	13.9% 72/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	17.9% 94/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	13.1% 69/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Haemoglobin decreased	17.0% 88/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	17.1% 90/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	15.0% 79/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Lipase increased	3.1% 16/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	10.6% 56/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	2.1% 11/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Neutrophil count decreased	22.0% 114/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	17.7% 93/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	19.6% 103/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Platelet count decreased	8.7% 45/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.8% 36/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.9% 52/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations Weight decreased	6.4% 33/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	3.8% 20/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.3% 28/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Investigations White blood cell count decreased	6.7% 35/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	7.8% 41/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	9.9% 52/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Metabolism and nutrition disorders Decreased appetite	5.0% 26/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.2% 22/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.8% 36/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 29/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	6.8% 36/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.8% 25/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Nervous system disorders Decreased vibratory sense	2.3% 12/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.7% 30/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.4% 23/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Nervous system disorders Dizziness	9.4% 49/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.5% 29/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.5% 29/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Nervous system disorders Headache	15.0% 78/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	17.1% 90/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	17.3% 91/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Nervous system disorders Hypoaesthesia	4.6% 24/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.0% 21/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.1% 27/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Nervous system disorders Peripheral sensory neuropathy	4.8% 25/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.1% 27/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	4.6% 24/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Pregnancy, puerperium and perinatal conditions Pregnancy	3.9% 20/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	5.7% 30/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	3.2% 17/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.
Respiratory, thoracic and mediastinal disorders Cough	15.6% 81/519 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	18.4% 97/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.	20.2% 106/526 • Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study). Standard Level reporting by DAIDS EAE Manual,May 6, 2004(http://rcc.tech-res.com/safetyandpharmacovigilance/). ATV-related, asymptomatic hyperbilirubinemia or jaundice without LFT elevation does not require (EAE) reporting. IRIS events do not fulfill the DAIDS EAE reporting criteria, even if the event is severe in intensity.