Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00084136
First received: June 7, 2004
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: July 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-infected, treatment-naive men and women, at least 18 years of age with CD4+ count <300 cells/mm^3.

Reporting Groups
  Description
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

Participant Flow for 2 periods

Period 1:   PI Comparison
    ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV
STARTED   519   526   0 
COMPLETED   464 [1]   479 [1]   0 
NOT COMPLETED   55   47   0 
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 2:   NRTI Comparison
    ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV
STARTED   519   0   526 
COMPLETED   418 [1]   0   444 [1] 
NOT COMPLETED   101   0   82 
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).



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV   Total 
Overall Participants Analyzed 
[Units: Participants]
 519   526   526   1571 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (9)   35  (8)   35  (9)   35  (9) 
Age, Customized 
[Units: 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 
Gender 
[Units: Participants]
       
Female   241   256   242   739 
Male   278   270   284   832 
Region of Enrollment 
[Units: 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] 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 163  (85)   167  (83)   155  (81)   162  (83) 
[1] Screening value used for study eligibility as no other pre-randomization CD4 cell counts available
CD4 count, Categorical [1] 
[Units: 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] Screening CD4 count used for study eligibility as no other pre-randomization counts available.
Plasma HIV-1 RNA, Continuous 
[Units: Log10 copies/mL]
Median (Inter-Quartile Range)
 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 
[Units: 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 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Time to Treatment Failure (PI Comparison)   [ 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). ]

Measure Type Primary
Measure Title Time to Treatment Failure (PI Comparison)
Measure 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).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Time to Treatment Failure (PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
 120 [2] 
 (96 to N/A) 
  
[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%


Statistical Analysis 1 for Time to Treatment Failure (PI Comparison)
Groups [1] ZDV/3TC+EFV vs. ddI+FTC+ATV
Method [2] Log Rank
P Value [3] <0.01
Hazard Ratio (HR) [4] 1.51
95% Confidence Interval 1.12 to 2.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Log-rank test was stratified by country and screening RNA (< 100,000 c/mL vs >= 100,000 copies/mL).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.
[4] Other relevant estimation information:
  The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.



2.  Primary:   Time to Treatment Failure (NRTI Comparison)   [ 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). ]

Measure Type Primary
Measure Title Time to Treatment Failure (NRTI Comparison)
Measure 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).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Treatment Failure (NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
    NA [1] 
 (216 to N/A) 
[1] Not estimable as the estimate for survival function at all weeks is above 75%


Statistical Analysis 1 for Time to Treatment Failure (NRTI Comparison)
Groups [1] ZDV/3TC+EFV vs. TDF/FTC+EFV
Method [2] Other
Hazard Ratio (HR) [3] 0.95
95% Confidence Interval 0.72 to 1.27
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.



3.  Secondary:   Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)   [ Time Frame: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008) ]

Measure Type Secondary
Measure Title Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants not starting study treatment excluded.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 518   522   0 
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
5th percentile   16 
 (8 to 22) 
 7 
 (3 to 11) 
  
10th percentile   34 
 (24 to 46) 
 18 
 (12 to 23) 
  
25th percentile   NA [1]   76 [2] 
 (50 to N/A) 
  
[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%

No statistical analysis provided for Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)



4.  Secondary:   Time to Immunologic Failure (PI Comparison)   [ Time Frame: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008) ]

Measure Type Secondary
Measure Title Time to Immunologic Failure (PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (ignoring current study treatment status or history)

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Time to Immunologic Failure (PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
1st percentile   48 
 (48 to 48) 
 48 
 (48 to 48) 
  
5th percentile   112 [1] 
 (48 to N/A) 
 NA [2] 
 (64 to N/A) 
  
[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%

No statistical analysis provided for Time to Immunologic Failure (PI Comparison)



5.  Secondary:   Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)   [ Time Frame: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008) ]

Measure Type Secondary
Measure Title Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT - ignoring both current treatment status and treatment history.

Reporting Groups
  Description
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

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
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) 
  

No statistical analysis provided for Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)



6.  Secondary:   Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)   [ Time Frame: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008) ]

Measure Type Secondary
Measure Title Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Measure 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)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 518   522   0 
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
  
[1] Not estimable as the upper limit for survival function at all weeks is above 50%

No statistical analysis provided for Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)



7.  Secondary:   Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)   [ Time Frame: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008) ]

Measure Type Secondary
Measure Title Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.

Reporting Groups
  Description
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

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) 
[Units: 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    

No statistical analysis provided for Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)



8.  Secondary:   Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)   [ Time Frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
5th percentile   0 
 (0 to 0) 
 0 
 (0 to 0) 
  
10th percentile   16 
 (8 to 32) 
 0 
 (0 to 0) 
  
25th percentile   NA [1]   48 [2] 
 (32 to N/A) 
  
[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%

No statistical analysis provided for Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)



9.  Secondary:   Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)   [ Time Frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008) ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   526   0 
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
  
[1] Not estimable as the upper limit for survival function at all weeks is above 75%

No statistical analysis provided for Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)



10.  Secondary:   Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)   [ Time Frame: Throughout follow-up until study closed (May 31,2010) ]

Measure Type Secondary
Measure Title Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants not starting study treatment excluded.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 518   0   525 
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
[1] Not estimable as the upper limit for survival function at all weeks is above 75%

No statistical analysis provided for Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)



11.  Secondary:   Time to Immunologic Failure (NRTI Comparison)   [ Time Frame: At or after Week 48 (including all follow-up through study closure - May 31,2010) ]

Measure Type Secondary
Measure Title Time to Immunologic Failure (NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Immunologic Failure (NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
1st percentile   48 
 (48 to 48) 
    48 
 (48 to 48) 
5th percentile   128 [1] 
 (48 to N/A) 
    104 [1] 
 (48 to N/A) 
10th percentile   NA [2] 
 (248 to N/A) 
    NA [3] 
[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%

No statistical analysis provided for Time to Immunologic Failure (NRTI Comparison)



12.  Secondary:   Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)   [ Time Frame: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010) ]

Measure Type Secondary
Measure Title Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT - ignoring both current treatment status and treatment history.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
     
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) 

No statistical analysis provided for Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)



13.  Secondary:   Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)   [ Time Frame: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010) ]

Measure Type Secondary
Measure Title Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) 
[Units: 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 

No statistical analysis provided for Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)



14.  Secondary:   Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)   [ Time Frame: Week 48 (using follow-up through study closure on May 31,2010) ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
5th percentile   0 
 (0 to 0) 
    0 
 (0 to 0) 
10th percentile   16 
 (0 to 32) 
    24 
 (0 to 32) 

No statistical analysis provided for Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)



15.  Secondary:   Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)   [ Time Frame: Week 96 (using follow-up through to study closure on May 31,2010) ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
    NA [2] 
[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%

No statistical analysis provided for Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)



16.  Secondary:   Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)   [ Time Frame: Week 48 using follow-up through study closure on May 31,2010 ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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] 
[1] Not estimable as all estimates for survival function at all weeks is above 75%

No statistical analysis provided for Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)



17.  Secondary:   Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)   [ Time Frame: Week 96 using follow-up through study closure on May 31,2010 ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 519   0   526 
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
[1] Not estimable as the estimates for survival function at all weeks is above 75%

No statistical analysis provided for Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)



18.  Secondary:   Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)   [ Time Frame: Throughout study follow-up until study closure (May 31, 2010) ]

Measure Type Secondary
Measure Title Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Measure 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)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.

Reporting Groups
  Description
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
TDF/FTC+EFV TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz

Measured Values
   ZDV/3TC+EFV   ddI+FTC+ATV   TDF/FTC+EFV 
Participants Analyzed 
[Units: Participants]
 518   0   525 
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) 
[Units: Weeks]
Number (95% Confidence Interval)
     
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 N/A) 
[1] Not estimable as the upper limit for survival function at all weeks is above 50%

No statistical analysis provided for Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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