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Optimizing Treatment for Treatment-Experienced, HIV-Infected People

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ClinicalTrials.gov Identifier: NCT00537394
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : August 7, 2014
Last Update Posted : May 26, 2016
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Enfuvirtide
Drug: Raltegravir
Drug: Darunavir
Drug: Tipranavir
Drug: Etravirine
Drug: Maraviroc
Enrollment 517
Recruitment Details Subjects recruited between February 2008 and May 2011 from participating ACTG, IMPAACT, and ATN network sites located in the continental US and Puerto Rico.
Pre-assignment Details A total of 104 exclusions among 517 enrolled to active screening but prior to assignment and dispensation of study treatment were due to any of the following: no resistance/tropism test results, not willing to accept any ARV study regimens, changes to current PI based ARV regimen or non-adherence, or changes with respect to eligibility criteria.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2
Hide Arm/Group Description [Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. [Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. [Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
Period Title: First Year of Follow-up
Started 181 179 53
Completed 169 [1] 168 [1] 50
Not Completed 12 11 3
Reason Not Completed
Death             7             0             0
Severe debilitation             1             0             1
Withdrawal by Subject             3             6             1
Lost to Follow-up             1             5             1
[1]
Completed refers to completing first 48 weeks of follow-up.
Period Title: 2nd Year of Follow-up
Started 169 168 50
Completed 158 159 44
Not Completed 11 9 6
Reason Not Completed
Death             4             1             2
Withdrawal by Subject             0             1             2
Lost to Follow-up             6             7             2
Clinic site closure             1             0             0
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2) Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2 Total
Hide Arm/Group Description Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued. Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible. Total of all reporting groups
Overall Number of Baseline Participants 181 179 53 413
Hide Baseline Analysis Population Description
Everyone randomized (ITT study sample), plus non-randomized group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 179 participants 53 participants 413 participants
<=18 years
6
   3.3%
8
   4.5%
3
   5.7%
17
   4.1%
Between 18 and 65 years
173
  95.6%
168
  93.9%
50
  94.3%
391
  94.7%
>=65 years
2
   1.1%
3
   1.7%
0
   0.0%
5
   1.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 179 participants 53 participants 413 participants
44.7  (10.8) 44.1  (11.7) 43.1  (10.7) 44.3  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 179 participants 53 participants 413 participants
Female
46
  25.4%
47
  26.3%
6
  11.3%
99
  24.0%
Male
135
  74.6%
132
  73.7%
47
  88.7%
314
  76.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 179 participants 53 participants 413 participants
Hispanic or Latino
37
  20.4%
46
  25.7%
14
  26.4%
97
  23.5%
Not Hispanic or Latino
141
  77.9%
132
  73.7%
38
  71.7%
311
  75.3%
Unknown or Not Reported
3
   1.7%
1
   0.6%
1
   1.9%
5
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 179 participants 53 participants 413 participants
American Indian or Alaska Native
3
   1.7%
2
   1.1%
1
   1.9%
6
   1.5%
Asian
0
   0.0%
4
   2.2%
1
   1.9%
5
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.2%
Black or African American
81
  44.8%
72
  40.2%
20
  37.7%
173
  41.9%
White
88
  48.6%
87
  48.6%
29
  54.7%
204
  49.4%
More than one race
1
   0.6%
2
   1.1%
0
   0.0%
3
   0.7%
Unknown or Not Reported
8
   4.4%
11
   6.1%
2
   3.8%
21
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 181 participants 179 participants 53 participants 413 participants
181 179 53 413
CD4 count, continuous  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 181 participants 179 participants 53 participants 413 participants
252.3  (194.9) 245.6  (195.1) 154.8  (170.1) 236.9  (194.2)
Plasma HIV-1 RNA, continuous  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 181 participants 179 participants 53 participants 413 participants
4.2
(3.6 to 4.7)
4.2
(3.6 to 4.6)
4.4
(4.1 to 4.8)
4.2
(3.6 to 4.6)
1.Primary Outcome
Title Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment
Hide Description Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method.
Time Frame From study entry to end of Week 48 evaluation window
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis uses intent to treat population, among the two randomized arms only.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.0
(19.6 to 32.3)
29.8
(23.1 to 36.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0), Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Comments Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-6.1 to 12.5
Estimation Comments Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.
2.Secondary Outcome
Title Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality
Hide Description Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality).
Time Frame From treatment dispensation to week 96 study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Only randomized participants included. Persons not starting study treatment excluded.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 180 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
3.1
(1.9 to 4.6)
3.9
(0.9 to 4.6)
25th percentile
24.7
(12.0 to 47.0)
25.3
(24.0 to 35.9)
50th percentile
NA [1] 
(72.1 to NA)
97.7 [2] 
(63.0 to NA)
[1]
Not estimable as the estimate and upper limit for survival function at all weeks is above 50%
[2]
Not estimable as the upper limit for survival function at all weeks is above 50%
3.Secondary Outcome
Title Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)
Hide Description First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization.
Time Frame From treatment dispensation to week 96 study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Only randomized participants included, and those who never started study treatment were excluded.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 180 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
9.0
(1.1 to 29.7)
24.0
(4.0 to 35.6)
10th percentile
31.1
(14.7 to 51.1)
38.0
(24.4 to 67.7)
25th percentile
98.0 [1] 
(82.7 to NA)
NA [2] 
(84.4 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 75%.
[2]
Not estimable as the estimate for survival function at all weeks is above 75%.
4.Secondary Outcome
Title Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment
Hide Description Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation.
Time Frame From randomization to week 96 study visit
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants included (i.e. ITT analysis).
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
1st percentile
0
(0 to 1)
0
(0 to 12)
5th percentile
36 [1] 
(1 to NA)
36
(4 to 36)
10th percentile
NA [2] 
(36 to NA)
48
(36 to 84)
[1]
Not estimable as the upper limit for survival function at all weeks is above 95%.
[2]
Not estimable as the estimate for survival function at all weeks is above 90%.
5.Secondary Outcome
Title Time From Randomization to Confirmed Virological Failure
Hide Description Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested.
Time Frame From randomization to week 96 study visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (all randomized participants) included.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
5th percentile
12
(8 to 12)
12
(8 to 12)
10th percentile
12
(12 to 16)
12
(12 to 16)
25th percentile
48 [1] 
(24 to NA)
48 [1] 
(36 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks is above 75%.
6.Secondary Outcome
Title Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml
Hide Description Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded.
Time Frame At Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Measure Type: Number
Unit of Measure: participants
Week 24: Number with RNA < 50 c/mL (N=170; N=171) 122 117
Week 48: Number with RNA < 50 c/mL (N=169; N=165) 112 106
Week 96: Number with RNA < 50 c/mL (N=158; N=158) 107 109
7.Secondary Outcome
Title Change in Plasma HIV-1 Viral Load From Baseline to Week 1
Hide Description Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL.
Time Frame From baseline to Week 1 evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 172 173
Median (Inter-Quartile Range)
Unit of Measure: log10 copies/mL
1.3
(0.9 to 1.6)
1.4
(0.9 to 1.6)
8.Secondary Outcome
Title Change in Summarized Quality of Life Score
Hide Description Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health).
Time Frame At study entry and Weeks 24, 48, 96
Hide Outcome Measure Data
Hide Analysis Population Description
Two randomized arms only.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Change from baseline to week 24 (N=165; N=165)
0
(-5 to 15)
5
(0 to 15)
Change from baseline to week 48 (N=161; N=158)
0
(-10 to 15)
0
(-5 to 10)
Change from baseline to week 96 (N=155; N=154)
0
(-5 to 15)
0.5
(-3 to 19)
9.Secondary Outcome
Title Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)
Hide Description Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent.
Time Frame At Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 180 177
Measure Type: Number
Unit of Measure: participants
Week 24 (N=170; N=172) 25 26
Week 48 (N=167; N=163) 30 26
10.Secondary Outcome
Title Change in Cardiovascular Risk Score From Baseline
Hide Description Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score.
Time Frame At Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 162 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 (N= 150; N=147) -0.7  (4.4) 0.3  (4.9)
Week 48 (N=143; N=144) 0.1  (4.3) 0.8  (4.9)
Week 96 (N=129; N=132) 0.5  (5.2) 1.1  (5.0)
11.Secondary Outcome
Title Change in CD4 Count From Baseline
Hide Description Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded.
Time Frame From study entry to Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the two randomized arms were assessed.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 181 179
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Change from entry to week 48 (N=166; N=163)
105.5
(46.0 to 214.0)
89.5
(33.0 to 166.5)
Change from entry to week 96 (N= 154; N=157)
140.8
(39.0 to 244.5)
115.5
(31.5 to 229.5)
12.Secondary Outcome
Title Time From Treatment Dispensation to Serious Non-AIDS-defining Events
Hide Description Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit.
Time Frame From treatment initiation to week 96 study visit
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants were included, and those not starting study treatment were excluded.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 180 177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: weeks
1st percentile
4.9
(1.9 to 26.0)
29.3
(23.1 to 41.3)
5th percentile
60.0 [1] 
(13.0 to NA)
NA [2] 
(31.7 to NA)
[1]
Not estimable as the upper limit for survival function at all weeks are above 95%.
[2]
Not estimable as the estimates and upper limit for survival function at all weeks are above 95%.
13.Secondary Outcome
Title Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry
Hide Description HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure.
Time Frame From study entry to time of confirmed virological failure (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 26 19
Measure Type: Number
Unit of Measure: participants
3 2
14.Secondary Outcome
Title Change in Fasting Non-HDL Cholesterol From Baseline
Hide Description Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded.
Time Frame From study entry to Weeks 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 180 177
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change from baseline to week 24 (N=131; N=121) 4.1  (35.8) 20.8  (39.8)
Change from baseline to week 48 (N=125 ; N=117) 7.6  (35.5) 19.8  (34.1)
15.Secondary Outcome
Title Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure
Hide Description Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir.
Time Frame Between baseline and confirmed virologic failure (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded.
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)
Hide Arm/Group Description:
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
Overall Number of Participants Analyzed 52 46
Measure Type: Number
Unit of Measure: participants
18 13
Time Frame AE data collected between date of first dose of study Rx, and end of week 96 study visit window (up to 110 weeks post entry), which may include follow-up/events after PCD . Those who never started study Rx are excluded from AE evaluation and analysis.
Adverse Event Reporting Description Randomized arms only. All SAEs (per ICH, regardless of relationship to treatment), all cancers, MIs and hepatic failures; grade>2 signs/symptoms per ACTG criteria; all AST, ALT, creatinine, creatinine clearance, urinalysis, fasting lipid & glucose, and other Grade>2 labs, and all S/Sx or labs that lead to a change in study treatment were requested.
 
Arm/Group Title Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)
Hide Arm/Group Description Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started. Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
All-Cause Mortality
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)
Affected / at Risk (%) Affected / at Risk (%)
Total   58/180 (32.22%)   49/177 (27.68%) 
Blood and lymphatic system disorders     
Anaemia † 1  2/180 (1.11%)  0/177 (0.00%) 
Febrile neutropenia † 1  0/180 (0.00%)  1/177 (0.56%) 
Neutropenia † 1  1/180 (0.56%)  2/177 (1.13%) 
Pancytopenia † 1  1/180 (0.56%)  0/177 (0.00%) 
Thrombocytopenia † 1  1/180 (0.56%)  1/177 (0.56%) 
Thrombocytosis † 1  0/180 (0.00%)  1/177 (0.56%) 
Cardiac disorders     
Angina pectoris † 1  0/180 (0.00%)  1/177 (0.56%) 
Angina unstable † 1  0/180 (0.00%)  1/177 (0.56%) 
Cardiac arrest † 1  1/180 (0.56%)  0/177 (0.00%) 
Cardiac failure † 1  1/180 (0.56%)  0/177 (0.00%) 
Myocardial infarction † 1  1/180 (0.56%)  2/177 (1.13%) 
Endocrine disorders     
Hyperthyroidism † 1  1/180 (0.56%)  0/177 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  0/180 (0.00%)  1/177 (0.56%) 
Gastrointestinal disorders     
Abdominal pain † 1  2/180 (1.11%)  0/177 (0.00%) 
Ascites † 1  1/180 (0.56%)  0/177 (0.00%) 
Diarrhoea † 1  3/180 (1.67%)  0/177 (0.00%) 
Dysphagia † 1  1/180 (0.56%)  0/177 (0.00%) 
Intestinal fistula † 1  0/180 (0.00%)  1/177 (0.56%) 
Intra-abdominal haemorrhage † 1  1/180 (0.56%)  0/177 (0.00%) 
Nausea † 1  1/180 (0.56%)  0/177 (0.00%) 
Pancreatitis † 1  1/180 (0.56%)  0/177 (0.00%) 
Small intestinal obstruction † 1  1/180 (0.56%)  0/177 (0.00%) 
Vomiting † 1  0/180 (0.00%)  1/177 (0.56%) 
General disorders     
Chest pain † 1  6/180 (3.33%)  6/177 (3.39%) 
Death † 1  0/180 (0.00%)  1/177 (0.56%) 
Device dislocation † 1  1/180 (0.56%)  0/177 (0.00%) 
Pyrexia † 1  0/180 (0.00%)  2/177 (1.13%) 
Hepatobiliary disorders     
Hepatic failure † 1  1/180 (0.56%)  0/177 (0.00%) 
Hepatotoxicity † 1  1/180 (0.56%)  0/177 (0.00%) 
Immune system disorders     
Autoimmune disorder † 1  1/180 (0.56%)  0/177 (0.00%) 
Hypersensitivity † 1  0/180 (0.00%)  2/177 (1.13%) 
Immune reconstitution inflammatory syndrome † 1  1/180 (0.56%)  0/177 (0.00%) 
Infections and infestations     
AIDS dementia complex † 1  1/180 (0.56%)  0/177 (0.00%) 
Abdominal wall infection † 1  0/180 (0.00%)  1/177 (0.56%) 
Abscess of salivary gland † 1  0/180 (0.00%)  1/177 (0.56%) 
Acute hepatitis B † 1  0/180 (0.00%)  1/177 (0.56%) 
Arthritis bacterial † 1  1/180 (0.56%)  0/177 (0.00%) 
Bronchitis † 1  0/180 (0.00%)  1/177 (0.56%) 
Bronchopneumonia † 1  1/180 (0.56%)  0/177 (0.00%) 
Cellulitis † 1  0/180 (0.00%)  4/177 (2.26%) 
Diverticulitis † 1  0/180 (0.00%)  1/177 (0.56%) 
Endometritis † 1  1/180 (0.56%)  0/177 (0.00%) 
Gastroenteritis † 1  1/180 (0.56%)  3/177 (1.69%) 
Gastroenteritis viral † 1  0/180 (0.00%)  1/177 (0.56%) 
Genital herpes † 1  1/180 (0.56%)  0/177 (0.00%) 
HIV wasting syndrome † 1  1/180 (0.56%)  0/177 (0.00%) 
Herpes oesophagitis † 1  1/180 (0.56%)  0/177 (0.00%) 
Herpes zoster † 1  0/180 (0.00%)  2/177 (1.13%) 
Influenza † 1  0/180 (0.00%)  1/177 (0.56%) 
Laryngitis † 1  1/180 (0.56%)  0/177 (0.00%) 
Liver abscess † 1  0/180 (0.00%)  1/177 (0.56%) 
Lobar pneumonia † 1  1/180 (0.56%)  1/177 (0.56%) 
Meningitis listeria † 1  1/180 (0.56%)  0/177 (0.00%) 
Mycobacterium avium complex infection † 1  0/180 (0.00%)  1/177 (0.56%) 
Parvovirus infection † 1  1/180 (0.56%)  0/177 (0.00%) 
Pneumocystis jirovecii pneumonia † 1  0/180 (0.00%)  1/177 (0.56%) 
Pneumonia † 1  7/180 (3.89%)  6/177 (3.39%) 
Pneumonia bacterial † 1  2/180 (1.11%)  2/177 (1.13%) 
Pneumonia viral † 1  1/180 (0.56%)  0/177 (0.00%) 
Post procedural infection † 1  1/180 (0.56%)  0/177 (0.00%) 
Postoperative wound infection † 1  0/180 (0.00%)  1/177 (0.56%) 
Progressive multifocal leukoencephalopathy † 1  1/180 (0.56%)  0/177 (0.00%) 
Sepsis † 1  0/180 (0.00%)  3/177 (1.69%) 
Urinary tract infection † 1  0/180 (0.00%)  1/177 (0.56%) 
Urosepsis † 1  1/180 (0.56%)  0/177 (0.00%) 
Viral infection † 1  0/180 (0.00%)  1/177 (0.56%) 
Viral upper respiratory tract infection † 1  1/180 (0.56%)  0/177 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture † 1  2/180 (1.11%)  1/177 (0.56%) 
Gun shot wound † 1  0/180 (0.00%)  1/177 (0.56%) 
Joint dislocation † 1  1/180 (0.56%)  0/177 (0.00%) 
Lower limb fracture † 1  0/180 (0.00%)  1/177 (0.56%) 
Multiple fractures † 1  0/180 (0.00%)  1/177 (0.56%) 
Overdose † 1  1/180 (0.56%)  0/177 (0.00%) 
Post procedural haematoma † 1  1/180 (0.56%)  0/177 (0.00%) 
Investigations     
Hepatic enzyme increased † 1  0/180 (0.00%)  1/177 (0.56%) 
Transaminases increased † 1  0/180 (0.00%)  1/177 (0.56%) 
Metabolism and nutrition disorders     
Dehydration † 1  0/180 (0.00%)  1/177 (0.56%) 
Gout † 1  1/180 (0.56%)  0/177 (0.00%) 
Hyperglycaemia † 1  0/180 (0.00%)  1/177 (0.56%) 
Hypokalaemia † 1  0/180 (0.00%)  1/177 (0.56%) 
Hyponatraemia † 1  1/180 (0.56%)  0/177 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness † 1  1/180 (0.56%)  0/177 (0.00%) 
Osteonecrosis † 1  0/180 (0.00%)  1/177 (0.56%) 
Pain in extremity † 1  1/180 (0.56%)  0/177 (0.00%) 
Rhabdomyolysis † 1  1/180 (0.56%)  0/177 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenosquamous cell lung cancer † 1  1/180 (0.56%)  0/177 (0.00%) 
Basal cell carcinoma † 1  1/180 (0.56%)  1/177 (0.56%) 
Breast cancer † 1  1/180 (0.56%)  0/177 (0.00%) 
Colon cancer metastatic † 1  1/180 (0.56%)  0/177 (0.00%) 
Diffuse large B-cell lymphoma † 1  1/180 (0.56%)  0/177 (0.00%) 
Hodgkin's disease † 1  1/180 (0.56%)  0/177 (0.00%) 
Meningioma † 1  1/180 (0.56%)  0/177 (0.00%) 
Plasmacytoma † 1  1/180 (0.56%)  0/177 (0.00%) 
Squamous cell carcinoma † 1  1/180 (0.56%)  1/177 (0.56%) 
Nervous system disorders     
Cerebrovascular accident † 1  0/180 (0.00%)  2/177 (1.13%) 
Convulsion † 1  1/180 (0.56%)  0/177 (0.00%) 
Headache † 1  1/180 (0.56%)  0/177 (0.00%) 
Neurological symptom † 1  0/180 (0.00%)  1/177 (0.56%) 
Radiculopathy † 1  0/180 (0.00%)  1/177 (0.56%) 
Syncope † 1  1/180 (0.56%)  1/177 (0.56%) 
VIIth nerve paralysis † 1  1/180 (0.56%)  1/177 (0.56%) 
Psychiatric disorders     
Bipolar I disorder † 1  0/180 (0.00%)  1/177 (0.56%) 
Mental status changes † 1  0/180 (0.00%)  1/177 (0.56%) 
Mood altered † 1  0/180 (0.00%)  1/177 (0.56%) 
Substance abuse † 1  0/180 (0.00%)  1/177 (0.56%) 
Suicidal ideation † 1  1/180 (0.56%)  2/177 (1.13%) 
Suicide attempt † 1  1/180 (0.56%)  2/177 (1.13%) 
Renal and urinary disorders     
Nephrolithiasis † 1  1/180 (0.56%)  0/177 (0.00%) 
Renal failure † 1  1/180 (0.56%)  0/177 (0.00%) 
Renal failure acute † 1  1/180 (0.56%)  1/177 (0.56%) 
Urinary incontinence † 1  0/180 (0.00%)  1/177 (0.56%) 
Reproductive system and breast disorders     
Ovarian cyst † 1  0/180 (0.00%)  1/177 (0.56%) 
Testicular torsion † 1  0/180 (0.00%)  1/177 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  1/180 (0.56%)  0/177 (0.00%) 
Cough † 1  1/180 (0.56%)  0/177 (0.00%) 
Epistaxis † 1  0/180 (0.00%)  1/177 (0.56%) 
Hiccups † 1  0/180 (0.00%)  1/177 (0.56%) 
Pneumonia aspiration † 1  1/180 (0.56%)  0/177 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash † 1  1/180 (0.56%)  0/177 (0.00%) 
Social circumstances     
Physical assault † 1  0/180 (0.00%)  1/177 (0.56%) 
Surgical and medical procedures     
Bartholin's cyst removal † 1  0/180 (0.00%)  1/177 (0.56%) 
Colostomy † 1  0/180 (0.00%)  1/177 (0.56%) 
Finger amputation † 1  1/180 (0.56%)  0/177 (0.00%) 
Inguinal hernia repair † 1  1/180 (0.56%)  0/177 (0.00%) 
Intervertebral disc operation † 1  0/180 (0.00%)  1/177 (0.56%) 
Vascular disorders     
Peripheral arterial occlusive disease † 1  0/180 (0.00%)  1/177 (0.56%) 
Venous thrombosis † 1  1/180 (0.56%)  0/177 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0) Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)
Affected / at Risk (%) Affected / at Risk (%)
Total   169/180 (93.89%)   165/177 (93.22%) 
Gastrointestinal disorders     
Diarrhoea † 1  8/180 (4.44%)  9/177 (5.08%) 
Nausea † 1  12/180 (6.67%)  6/177 (3.39%) 
General disorders     
Fatigue † 1  9/180 (5.00%)  8/177 (4.52%) 
Pyrexia † 1  7/180 (3.89%)  11/177 (6.21%) 
Infections and infestations     
Bronchitis † 1  12/180 (6.67%)  12/177 (6.78%) 
Herpes simplex † 1  6/180 (3.33%)  9/177 (5.08%) 
Herpes zoster † 1  5/180 (2.78%)  10/177 (5.65%) 
Oral candidiasis † 1  10/180 (5.56%)  6/177 (3.39%) 
Pneumonia bacterial † 1  12/180 (6.67%)  11/177 (6.21%) 
Upper respiratory tract infection † 1  16/180 (8.89%)  14/177 (7.91%) 
Urinary tract infection † 1  4/180 (2.22%)  9/177 (5.08%) 
Investigations     
Alanine aminotransferase increased † 1  38/180 (21.11%)  41/177 (23.16%) 
Aspartate aminotransferase increased † 1  50/180 (27.78%)  47/177 (26.55%) 
Blood alkaline phosphatase increased † 1  11/180 (6.11%)  4/177 (2.26%) 
Blood bilirubin increased † 1  9/180 (5.00%)  6/177 (3.39%) 
Blood cholesterol † 1  8/180 (4.44%)  11/177 (6.21%) 
Blood cholesterol abnormal † 1  70/180 (38.89%)  82/177 (46.33%) 
Blood cholesterol increased † 1  11/180 (6.11%)  22/177 (12.43%) 
Blood creatinine increased † 1  26/180 (14.44%)  30/177 (16.95%) 
Blood glucose abnormal † 1  54/180 (30.00%)  62/177 (35.03%) 
Blood glucose decreased † 1  19/180 (10.56%)  15/177 (8.47%) 
Blood glucose increased † 1  30/180 (16.67%)  37/177 (20.90%) 
Blood potassium decreased † 1  3/180 (1.67%)  9/177 (5.08%) 
Blood triglycerides † 1  12/180 (6.67%)  12/177 (6.78%) 
Low density lipoprotein † 1  17/180 (9.44%)  22/177 (12.43%) 
Low density lipoprotein abnormal † 1  48/180 (26.67%)  47/177 (26.55%) 
Low density lipoprotein increased † 1  9/180 (5.00%)  13/177 (7.34%) 
Neutrophil count decreased † 1  21/180 (11.67%)  9/177 (5.08%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  10/180 (5.56%)  6/177 (3.39%) 
Nervous system disorders     
Headache † 1  14/180 (7.78%)  13/177 (7.34%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  12/180 (6.67%)  3/177 (1.69%) 
Vascular disorders     
Hypertension † 1  6/180 (3.33%)  10/177 (5.65%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[Not Specified]
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 Trials 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 & Scientific Systems, Inc.
Phone: (301)628-3313
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00537394     History of Changes
Other Study ID Numbers: A5241
10395 ( Registry Identifier: DAIDS ES )
ACTG A5241
OPTIONS
First Submitted: September 27, 2007
First Posted: October 1, 2007
Results First Submitted: June 14, 2013
Results First Posted: August 7, 2014
Last Update Posted: May 26, 2016