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

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ClinicalTrials.gov Identifier: NCT00084136
Recruitment Status : Completed
First Posted : June 8, 2004
Results First Posted : August 9, 2011
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Atazanavir
Drug: Didanosine (enteric-coated)
Drug: Efavirenz
Drug: Emtricitabine
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lamivudine/Zidovudine
Enrollment 1571
Recruitment Details 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.
Pre-assignment Details HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count <300 cells/mm^3.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz

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 participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Period Title: PI Comparison
Started 519 526 0
Completed 464 [1] 479 [1] 0
Not Completed 55 47 0
Reason Not Completed
Death             10             9             0
Lost to Follow-up             11             8             0
Withdrawal by Subject             33             30             0
Clinic site closed             1             0             0
[1]
Follow-up was until ddI+FTC+ATV arm was closed per DSMB recommendation on May 23, 2008.
Period Title: NRTI Comparison
Started 519 0 526
Completed 418 [1] 0 444 [1]
Not Completed 101 0 82
Reason Not Completed
Death             20             0             18
Lost to Follow-up             14             0             12
Withdrawal by Subject             54             0             38
Clinic site closed             12             0             14
Not reason above             1             0             0
[1]
Follow-up though study closeout period (final visit between April 1 and May 31, 2010).
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV Total
Hide Arm/Group Description ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz

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 participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz Total of all reporting groups
Overall Number of Baseline Participants 519 526 526 1571
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
35  (9) 35  (8) 35  (9) 35  (9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
Between 18 and 29 years 141 146 146 433
Between 30 and 39 years 244 221 225 690
Between 40 and 49 years 100 129 116 345
At least 50 years 34 30 39 103
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
Female
241
  46.4%
256
  48.7%
242
  46.0%
739
  47.0%
Male
278
  53.6%
270
  51.3%
284
  54.0%
832
  53.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
Brazil 79 76 76 231
Haiti 35 32 33 100
India 81 86 88 255
Malawi 74 74 73 221
Peru 42 48 44 134
South Africa 70 70 70 210
Thailand 32 33 35 100
United States 70 70 70 210
Zimbabwe 36 37 37 110
CD4 count, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
163  (85) 167  (83) 155  (81) 162  (83)
[1]
Measure Description: Screening value used for study eligibility as no other pre-randomization CD4 cell counts available
CD4 count, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
< 50 cells/mm^3 68 63 69 200
Between 50 and 99 cells/mm^3 70 77 82 229
Between 100 and 199 cells/mm^3 174 161 193 528
Between 200 and 249 cells/mm^3 104 128 107 339
Between 250 and 299 cells/mm^3 103 97 75 275
[1]
Measure Description: Screening CD4 count used for study eligibility as no other pre-randomization counts available.
Plasma HIV-1 RNA, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
5.0
(4.6 to 5.4)
5.1
(4.5 to 5.5)
5.0
(4.5 to 5.5)
5.0
(4.6 to 5.5)
Plasma HIV-1 RNA, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 519 participants 526 participants 526 participants 1571 participants
<= 400 copies/mL 3 6 3 12
Between 400 and 4000 copies/mL 22 19 14 55
Between 4001 and 40,000 copies/mL 103 119 124 346
Between 40,001 and 400,000 copies/mL 311 283 284 878
Between 400,001 and 749,999 copies/mL 45 58 55 158
>= 750,000 copies/mL 35 40 46 121
Missing 0 1 0 1
1.Primary Outcome
Title Time to Treatment Failure (PI Comparison)
Hide Description 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).
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
16
(16 to 24)
16
(16 to 16)
10th percentile
40
(24 to 64)
24
(16 to 32)
25th percentile
NA [1] 
(152 to NA)
120 [2] 
(96 to NA)
[1]
Not estimable as the estimate for survival function at all weeks is above 75%
[2]
Not estimable as the upper limit for survival function at all weeks is above 75%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZDV/3TC+EFV, ddI+FTC+ATV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.
Method Log Rank
Comments Log-rank test was stratified by country and screening RNA (< 100,000 c/mL vs >= 100,000 copies/mL).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.12 to 2.04
Estimation Comments The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.
2.Primary Outcome
Title Time to Treatment Failure (NRTI Comparison)
Hide Description 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).
Time Frame Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
16
(16 to 24)
16
(16 to 24)
10th percentile
40
(24 to 71)
40
(24 to 64)
25th percentile
NA [1] 
(224 to NA)
NA [1] 
(216 to NA)
[1]
Not estimable as the estimate for survival function at all weeks is above 75%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ZDV/3TC+EFV, TDF/FTC+EFV
Comments While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.72 to 1.27
Estimation Comments The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.
3.Secondary Outcome
Title Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Hide Description 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).
Time Frame Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not starting study treatment excluded.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 518 522 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
16
(8 to 22)
7
(3 to 11)
10th percentile
34
(24 to 46)
18
(12 to 23)
25th percentile
NA [1] 
(NA to NA)
76 [2] 
(50 to NA)
[1]
Not estimable as the estimates for survival function at all weeks is above 75%
[2]
Not estimable as the upper limit for survival function at all weeks is above 75%
4.Secondary Outcome
Title Time to Immunologic Failure (PI Comparison)
Hide Description Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
Time Frame At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (ignoring current study treatment status or history)
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
1st percentile
48
(48 to 48)
48
(48 to 48)
5th percentile
112 [1] 
(48 to NA)
NA [2] 
(64 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 5%
[2]
Not estimable as the estimate for survival function at all weeks is above 5%
5.Secondary Outcome
Title Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Hide Description 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).
Time Frame weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - ignoring both current treatment status and treatment history.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz

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 participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Change from screening to week 24 (N=490; N=502)
112.5
(57.0 to 185.0)
146.5
(79.0 to 224.0)
Change from screening to week 48 (N=474; N=477)
152.0
(84.0 to 236.0)
187.0
(111.0 to 272.0)
Change from screening to week 96 (N= 188; N=188)
216.0
(149.0 to 300.5)
256.0
(142.5 to 371.0)
6.Secondary Outcome
Title Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Hide Description 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.
Time Frame Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 518 522 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
10th percentile
4
(4 to 4)
4
(4 to 8)
25th percentile
12
(12 to 16)
32
(20 to 40)
50th percentile
96
(72 to 144)
144 [1] 
(120 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 50%
7.Secondary Outcome
Title Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Hide Description 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.
Time Frame At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz

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 participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Measure Type: Number
Unit of Measure: participants
Week 24: Number with RNA <400 c/mL (N=495; N=506) 459 431
Week 48: Number with RNA <400 c/mL (N=476; N=478) 437 424
8.Secondary Outcome
Title Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Hide Description 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.
Time Frame Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Hide Outcome Measure Data
Hide Analysis Population Description
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
16
(8 to 32)
0
(0 to 0)
25th percentile
NA [1] 
(NA to NA)
48 [2] 
(32 to NA)
[1]
Not estimable as the estimates for survival function at all weeks is above 75%
[2]
Not estimable as the upper limit for survival function at all weeks is above 75%
9.Secondary Outcome
Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Hide Description 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.
Time Frame Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 526 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
0
(0 to 0)
0
(0 to 0)
25th percentile
32
(16 to 48)
48 [1] 
(32 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 75%
10.Secondary Outcome
Title Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Hide Description 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).
Time Frame Throughout follow-up until study closed (May 31,2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants not starting study treatment excluded.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 518 0 525
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
16
(8 to 23)
18
(8 to 24)
10th percentile
34
(24 to 45)
36
(24 to 48)
25th percentile
163
(120 to 200)
201 [1] 
(160 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 75%
11.Secondary Outcome
Title Time to Immunologic Failure (NRTI Comparison)
Hide Description Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
Time Frame At or after Week 48 (including all follow-up through study closure - May 31,2010)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
1st percentile
48
(48 to 48)
48
(48 to 48)
5th percentile
128 [1] 
(48 to NA)
104 [1] 
(48 to NA)
10th percentile
NA [2] 
(248 to NA)
NA [3] 
(NA to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 95%
[2]
Not estimable as the estimates for survival function at all weeks is above 90%
[3]
Not estimable as all estimates for survival function at all weeks is above 90%
12.Secondary Outcome
Title Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Hide Description 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).
Time Frame weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - ignoring both current treatment status and treatment history.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Change from screening to week 24 (N=490; N=498)
112.5
(57 to 185)
120.5
(67 to 181)
Change from screening to week 48 (N=480; N=485)
151.5
(84 to 233.5)
159
(97 to 237)
Change from screening to week 96 (N=458; N=471)
220.5
(143 to 313)
226
(142 to 321)
13.Secondary Outcome
Title Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Hide Description 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.
Time Frame At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
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Hide Analysis Population Description
ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Unit of Measure: participants
Week 24: Number with RNA <400 c/mL (N=495; N=500) 459 448
Week 48: Number with RNA <400 c/mL (N=482; N=487) 442 455
14.Secondary Outcome
Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Hide Description 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.
Time Frame Week 48 (using follow-up through study closure on May 31,2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
16
(0 to 32)
24
(0 to 32)
15.Secondary Outcome
Title Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Hide Description 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.
Time Frame Week 96 (using follow-up through to study closure on May 31,2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
16
(0 to 32)
24
(0 to 32)
25th percentile
NA [1] 
(88 to NA)
NA [2] 
(NA to NA)
[1]
Not estimable as the estimates for survival function at all weeks is above 75%
[2]
Not estimable as all estimates for survival function at all weeks is above 75%
16.Secondary Outcome
Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Hide Description 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.
Time Frame Week 48 using follow-up through study closure on May 31,2010
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
0
(0 to 0)
0
(0 to 24)
25th percentile
32
(16 to 48)
NA [1] 
(NA to NA)
[1]
Not estimable as all estimates for survival function at all weeks is above 75%
17.Secondary Outcome
Title Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Hide Description 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.
Time Frame Week 96 using follow-up through study closure on May 31,2010
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 519 0 526
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
0
(0 to 0)
0
(0 to 0)
10th percentile
0
(0 to 0)
0
(0 to 24)
25th percentile
32
(16 to 56)
NA [1] 
(80 to NA)
[1]
Not estimable as the estimates for survival function at all weeks is above 75%
18.Secondary Outcome
Title Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Hide Description 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.
Time Frame Throughout study follow-up until study closure (May 31, 2010)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description:
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Overall Number of Participants Analyzed 518 0 525
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
10th percentile
4
(4 to 4)
4
(4 to 8)
25th percentile
12
(12 to 16)
32
(24 to 48)
50th percentile
112
(72 to 136)
224 [1] 
(192 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 50%
Time Frame Throughout study follow-up (until May 31, 2010 or earlier only if participant prematurely left the study).
Adverse Event Reporting Description 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.
 
Arm/Group Title ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   86/519 (16.57%)   84/526 (15.97%)   55/526 (10.46%) 
Blood and lymphatic system disorders       
Anaemia  1  12/519 (2.31%)  2/526 (0.38%)  2/526 (0.38%) 
Bone marrow failure  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Bone marrow toxicity  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Neutropenia  1  17/519 (3.28%)  8/526 (1.52%)  2/526 (0.38%) 
Pancytopenia  1  0/519 (0.00%)  2/526 (0.38%)  0/526 (0.00%) 
Thrombocytopenia  1  2/519 (0.39%)  2/526 (0.38%)  1/526 (0.19%) 
Cardiac disorders       
Acute coronary syndrome  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Angina pectoris  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Arrhythmia  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Cardiac failure congestive  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Hypertrophic cardiomyopathy  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Myocardial infarction  1  1/519 (0.19%)  0/526 (0.00%)  1/526 (0.19%) 
Ear and labyrinth disorders       
Vertigo  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Gastrointestinal disorders       
Abdominal pain  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Ascites  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Diarrhoea  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Intestinal obstruction  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Oesophageal ulcer  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Pancreatitis  1  2/519 (0.39%)  5/526 (0.95%)  0/526 (0.00%) 
Pancreatitis acute  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Pancreatitis chronic  1  1/519 (0.19%)  1/526 (0.19%)  0/526 (0.00%) 
Peritonitis  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Vomiting  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
General disorders       
Death  1  4/519 (0.77%)  0/526 (0.00%)  1/526 (0.19%) 
Pyrexia  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Sudden death  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Hepatobiliary disorders       
Hepatitis  1  4/519 (0.77%)  5/526 (0.95%)  1/526 (0.19%) 
Hepatorenal syndrome  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Hepatotoxicity  1  2/519 (0.39%)  0/526 (0.00%)  2/526 (0.38%) 
Hyperbilirubinaemia  1  1/519 (0.19%)  8/526 (1.52%)  0/526 (0.00%) 
Jaundice cholestatic  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  1/519 (0.19%)  2/526 (0.38%)  0/526 (0.00%) 
Hypersensitivity  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Infections and infestations       
AIDS related complex  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Abortion infected  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Bronchopneumonia  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Chikungunya virus infection  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Corynebacterium sepsis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Cryptococcosis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Disseminated tuberculosis  1  0/519 (0.00%)  1/526 (0.19%)  2/526 (0.38%) 
Encephalitis viral  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Gastroenteritis  1  2/519 (0.39%)  4/526 (0.76%)  1/526 (0.19%) 
HIV infection  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Herpes zoster  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Lower respiratory tract infection  1  2/519 (0.39%)  1/526 (0.19%)  0/526 (0.00%) 
Malaria  1  0/519 (0.00%)  1/526 (0.19%)  1/526 (0.19%) 
Meningitis  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Meningitis tuberculous  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Pneumocystis jiroveci pneumonia  1  1/519 (0.19%)  0/526 (0.00%)  1/526 (0.19%) 
Pneumonia  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Pneumonia bacterial  1  0/519 (0.00%)  1/526 (0.19%)  1/526 (0.19%) 
Progressive multifocal leukoencephalopathy  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Psoas abscess  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Pulmonary tuberculosis  1  1/519 (0.19%)  1/526 (0.19%)  0/526 (0.00%) 
Sepsis  1  1/519 (0.19%)  0/526 (0.00%)  2/526 (0.38%) 
Septic shock  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Tuberculosis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Injury, poisoning and procedural complications       
Gun shot wound  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Stab wound  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  0/519 (0.00%)  2/526 (0.38%)  1/526 (0.19%) 
Aspartate aminotransferase increased  1  1/519 (0.19%)  2/526 (0.38%)  1/526 (0.19%) 
Blood alkaline phosphatase increased  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Blood bilirubin increased  1  0/519 (0.00%)  8/526 (1.52%)  2/526 (0.38%) 
Blood creatine increased  1  0/519 (0.00%)  0/526 (0.00%)  2/526 (0.38%) 
Blood creatine phosphokinase increased  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Blood creatinine increased  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Blood glucose increased  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Blood lactic acid increased  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Blood phosphorus decreased  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Haemoglobin decreased  1  0/519 (0.00%)  1/526 (0.19%)  2/526 (0.38%) 
Hepatic enzyme increased  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Lipase increased  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Liver function test abnormal  1  2/519 (0.39%)  3/526 (0.57%)  2/526 (0.38%) 
Neutrophil count decreased  1  5/519 (0.96%)  4/526 (0.76%)  0/526 (0.00%) 
Weight decreased  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Metabolism and nutrition disorders       
Abnormal loss of weight  1  1/519 (0.19%)  2/526 (0.38%)  0/526 (0.00%) 
Dehydration  1  1/519 (0.19%)  1/526 (0.19%)  0/526 (0.00%) 
Diabetes mellitus  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Diabetic ketoacidosis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Hyperkalaemia  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Hypernatraemia  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Hypertriglyceridaemia  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Hypophosphataemia  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Lactic acidosis  1  2/519 (0.39%)  2/526 (0.38%)  0/526 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Gastric cancer  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Lymphoma  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Non-Hodgkin's lymphoma  1  1/519 (0.19%)  1/526 (0.19%)  0/526 (0.00%) 
Squamous cell carcinoma of the cervix  1  0/519 (0.00%)  2/526 (0.38%)  0/526 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage  1  1/519 (0.19%)  0/526 (0.00%)  1/526 (0.19%) 
Cerebral infarction  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Cranial nerve paralysis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Dizziness  1  1/519 (0.19%)  0/526 (0.00%)  1/526 (0.19%) 
Encephalitis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Haemorrhage intracranial  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Hepatic encephalopathy  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Hydrocephalus  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Ischaemic stroke  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Monoplegia  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Subarachnoid haemorrhage  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Pregnancy, puerperium and perinatal conditions       
Abortion missed  1  1/519 (0.19%)  1/526 (0.19%)  0/526 (0.00%) 
Abortion spontaneous  1  3/519 (0.58%)  5/526 (0.95%)  2/526 (0.38%) 
Abortion spontaneous complete  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Abortion spontaneous incomplete  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Blighted ovum  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Intra-uterine death  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Stillbirth  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Psychiatric disorders       
Completed suicide  1  2/519 (0.39%)  0/526 (0.00%)  1/526 (0.19%) 
Depression  1  0/519 (0.00%)  0/526 (0.00%)  2/526 (0.38%) 
Major depression  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Mental disorder  1  0/519 (0.00%)  0/526 (0.00%)  1/526 (0.19%) 
Psychotic disorder  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Suicidal ideation  1  2/519 (0.39%)  1/526 (0.19%)  3/526 (0.57%) 
Suicide attempt  1  1/519 (0.19%)  2/526 (0.38%)  5/526 (0.95%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Renal colic  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Renal failure  1  1/519 (0.19%)  0/526 (0.00%)  1/526 (0.19%) 
Renal failure acute  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Skin and subcutaneous tissue disorders       
Dapsone syndrome  1  0/519 (0.00%)  1/526 (0.19%)  0/526 (0.00%) 
Rash  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Stevens-Johnson syndrome  1  1/519 (0.19%)  1/526 (0.19%)  1/526 (0.19%) 
Surgical and medical procedures       
Abortion induced  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Thrombosis  1  1/519 (0.19%)  0/526 (0.00%)  0/526 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZDV/3TC+EFV ddI+FTC+ATV TDF/FTC+EFV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   481/519 (92.68%)   521/526 (99.05%)   489/526 (92.97%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  27/519 (5.20%)  24/526 (4.56%)  30/526 (5.70%) 
Eye disorders       
Ocular icterus  1  7/519 (1.35%)  49/526 (9.32%)  12/526 (2.28%) 
Gastrointestinal disorders       
Abdominal pain  1  39/519 (7.51%)  57/526 (10.84%)  52/526 (9.89%) 
Diarrhoea  1  43/519 (8.29%)  46/526 (8.75%)  63/526 (11.98%) 
Nausea  1  48/519 (9.25%)  44/526 (8.37%)  36/526 (6.84%) 
Vomiting  1  60/519 (11.56%)  47/526 (8.94%)  50/526 (9.51%) 
General disorders       
Chest pain  1  34/519 (6.55%)  37/526 (7.03%)  28/526 (5.32%) 
Pain  1  36/519 (6.94%)  43/526 (8.17%)  42/526 (7.98%) 
Pyrexia  1  96/519 (18.50%)  120/526 (22.81%)  112/526 (21.29%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  4/519 (0.77%)  34/526 (6.46%)  6/526 (1.14%) 
Infections and infestations       
Herpes zoster  1  38/519 (7.32%)  41/526 (7.79%)  33/526 (6.27%) 
Malaria  1  43/519 (8.29%)  44/526 (8.37%)  40/526 (7.60%) 
Oral candidiasis  1  24/519 (4.62%)  23/526 (4.37%)  27/526 (5.13%) 
Pharyngitis  1  19/519 (3.66%)  20/526 (3.80%)  28/526 (5.32%) 
Pneumonia bacterial  1  28/519 (5.39%)  30/526 (5.70%)  28/526 (5.32%) 
Upper respiratory tract infection  1  37/519 (7.13%)  37/526 (7.03%)  45/526 (8.56%) 
Investigations       
Alanine aminotransferase increased  1  220/519 (42.39%)  261/526 (49.62%)  265/526 (50.38%) 
Aspartate aminotransferase increased  1  269/519 (51.83%)  304/526 (57.79%)  289/526 (54.94%) 
Blood albumin abnormal  1  174/519 (33.53%)  188/526 (35.74%)  188/526 (35.74%) 
Blood alkaline phosphatase increased  1  18/519 (3.47%)  37/526 (7.03%)  24/526 (4.56%) 
Blood bicarbonate abnormal  1  35/519 (6.74%)  60/526 (11.41%)  48/526 (9.13%) 
Blood bilirubin increased  1  44/519 (8.48%)  397/526 (75.48%)  39/526 (7.41%) 
Blood phosphorus decreased  1  75/519 (14.45%)  87/526 (16.54%)  80/526 (15.21%) 
Blood potassium decreased  1  30/519 (5.78%)  29/526 (5.51%)  39/526 (7.41%) 
Blood sodium decreased  1  72/519 (13.87%)  94/526 (17.87%)  69/526 (13.12%) 
Haemoglobin decreased  1  88/519 (16.96%)  90/526 (17.11%)  79/526 (15.02%) 
Lipase increased  1  16/519 (3.08%)  56/526 (10.65%)  11/526 (2.09%) 
Neutrophil count decreased  1  114/519 (21.97%)  93/526 (17.68%)  103/526 (19.58%) 
Platelet count decreased  1  45/519 (8.67%)  36/526 (6.84%)  52/526 (9.89%) 
Weight decreased  1  33/519 (6.36%)  20/526 (3.80%)  28/526 (5.32%) 
White blood cell count decreased  1  35/519 (6.74%)  41/526 (7.79%)  52/526 (9.89%) 
Metabolism and nutrition disorders       
Decreased appetite  1  26/519 (5.01%)  22/526 (4.18%)  36/526 (6.84%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  29/519 (5.59%)  36/526 (6.84%)  25/526 (4.75%) 
Nervous system disorders       
Decreased vibratory sense  1  12/519 (2.31%)  30/526 (5.70%)  23/526 (4.37%) 
Dizziness  1  49/519 (9.44%)  29/526 (5.51%)  29/526 (5.51%) 
Headache  1  78/519 (15.03%)  90/526 (17.11%)  91/526 (17.30%) 
Hypoaesthesia  1  24/519 (4.62%)  21/526 (3.99%)  27/526 (5.13%) 
Peripheral sensory neuropathy  1  25/519 (4.82%)  27/526 (5.13%)  24/526 (4.56%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  20/519 (3.85%)  30/526 (5.70%)  17/526 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  81/519 (15.61%)  97/526 (18.44%)  106/526 (20.15%) 
Dyspnoea  1  32/519 (6.17%)  28/526 (5.32%)  23/526 (4.37%) 
Nasal congestion  1  20/519 (3.85%)  27/526 (5.13%)  27/526 (5.13%) 
Oropharyngeal pain  1  30/519 (5.78%)  39/526 (7.41%)  31/526 (5.89%) 
Productive cough  1  26/519 (5.01%)  26/526 (4.94%)  22/526 (4.18%) 
Rhinorrhoea  1  38/519 (7.32%)  44/526 (8.37%)  57/526 (10.84%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  37/519 (7.13%)  38/526 (7.22%)  25/526 (4.75%) 
Rash  1  33/519 (6.36%)  38/526 (7.22%)  36/526 (6.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00084136     History of Changes
Other Study ID Numbers: ACTG A5175
1U01AI068636 ( U.S. NIH Grant/Contract )
PEARLS
A5185s
5K24AI051966-03 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2004
First Posted: June 8, 2004
Results First Submitted: July 13, 2011
Results First Posted: August 9, 2011
Last Update Posted: October 10, 2018