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Trial record 33 of 42 for:    " January 12, 2011":" February 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Study of Options for Second-Line Effective Combination Therapy (SELECT) (SELECT)

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ClinicalTrials.gov Identifier: NCT01352715
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: Lopinavir/ritonavir
Drug: Raltegravir
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Abacavir/lamivudine/zidovudine
Drug: Abacavir/lamivudine
Drug: Lamivudine/zidovudine
Drug: Abacavir
Drug: Zidovudine
Drug: Lamivudine
Enrollment 515
Recruitment Details Recruited at international AIDS Clinical Trials Group Units. Recruitment occurred between March 13, 2012 (date first participant was randomized) and October 2, 2013 (date last participant was randomized).
Pre-assignment Details 515 were randomized 1:1 to treatment arms A and B.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Period Title: Overall Study
Started 260 255
Completed 215 209
Not Completed 45 46
Reason Not Completed
Death             3             3
Lost to Follow-up             5             7
Withdrawal by Subject             4             8
site closure             16             15
no final visit in closeout period             15             12
major ineligibility             2             1
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs Total
Hide Arm/Group Description

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Total of all reporting groups
Overall Number of Baseline Participants 258 254 512
Hide Baseline Analysis Population Description
Intention to treat: All 512 participants without a major eligibility violation.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 254 participants 512 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
258
 100.0%
254
 100.0%
512
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants 254 participants 512 participants
40  (8) 38  (8) 39  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants 254 participants 512 participants
Female
134
  51.9%
126
  49.6%
260
  50.8%
Male
124
  48.1%
128
  50.4%
252
  49.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 258 participants 254 participants 512 participants
White Non-Hispanic 0 1 1
Black Non-Hispanic 164 162 326
Hispanic (Regardless of Race) 11 9 20
Asian, Pacific Islander 83 82 165
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 258 participants 254 participants 512 participants
Malawi 56 55 111
South Africa 52 51 103
India 80 78 158
Zimbabwe 24 23 47
Kenya 24 24 48
Peru 5 4 9
Brazil 6 6 12
Tanzania 8 9 17
Thailand 3 4 7
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 258 participants 254 participants 512 participants
4.6  (0.8) 4.5  (0.9) 4.5  (0.8)
CD4+ T-cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 258 participants 254 participants 512 participants
178  (170) 182  (160) 180  (165)
1.Primary Outcome
Title Cumulative Probability of Virologic Failure by Week 48
Hide Description The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.
Time Frame From study entry to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 254
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative probability per 100 persons
10.3
(6.5 to 14.0)
12.4
(8.3 to 16.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: LPV/r Plus RAL, Arm B: LPV/r Plus Best Available NRTIs
Comments Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.
Method of Estimation Estimation Parameter Cumulative probability difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-8.4 to 1.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in CD4+ Cell Count From Baseline to Week 48
Hide Description Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.
Time Frame Study entry and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 246 242
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
199
(181 to 218)
190
(171 to 209)
3.Secondary Outcome
Title Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
Hide Description Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.
Time Frame From study entry through to week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 39 45
Measure Type: Number
Unit of Measure: participants
No new IAS mutations 29 32
1-2 new IAS mutations 9 13
3 new IAS mutations 1 0
4.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
Hide Description The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.
Time Frame From start of randomized treatment to off randomized treatment (up to 96 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As treated: Participants on randomized treatment are included in this analysis.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 253
Measure Type: Number
Unit of Measure: participants
62 81
5.Secondary Outcome
Title Number of Participants Discontinuing Randomized Treatment for Toxicity
Hide Description Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.
Time Frame From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 253
Measure Type: Number
Unit of Measure: participants
3 3
6.Secondary Outcome
Title Number of Participants With a New AIDS-defining Events or Death
Hide Description AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)
Time Frame From study entry throughout follow-up (up to 96 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 254
Measure Type: Number
Unit of Measure: participants
15 17
7.Secondary Outcome
Title Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
Hide Description Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes
Time Frame From study entry throughout follow-up (up to 96 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 254
Measure Type: Number
Unit of Measure: participants
7 7
8.Secondary Outcome
Title Percentage of Time Spent in Hospital
Hide Description The percentage of total study time that participants were in hospital.
Time Frame From study entry throughout follow-up (up to 96 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 254
Measure Type: Number
Unit of Measure: percentage of time spent in hospital
0.08 0.12
9.Secondary Outcome
Title Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
Hide Description Fasting was for 8 hours and the metabolic panel was drawn locally.
Time Frame Study entry and week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223)
Arm/Group Title Arm A: LPV/r Plus RAL Arm B: LPV/r Plus Best Available NRTIs
Hide Arm/Group Description:

Participants were administered LPV/r plus RAL orally twice daily.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.

Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily.

Lamivudine: Lamivudine 150 mg tablet orally twice daily.

Overall Number of Participants Analyzed 258 254
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
total cholesterol change
31
(24 to 38)
15
(9 to 20)
high-density lipoprotein (HDL) cholesterol change
4
(2 to 6)
2
(0 to 4)
low-density lipoprotein (LDL) cholesterol change
17
(12 to 21)
10
(6 to 15)
triglycerides change
80
(51 to 109)
31
(13 to 49)
glucose change
2
(0 to 5)
3
(2 to 5)
Time Frame From study entry throughout follow-up (up to 96 weeks)
Adverse Event Reporting Description The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed "Manual for Expedited Reporting of Adverse Events to DAIDS" (DAIDS EAE Manual), version 2.0 January, 2010.
 
Arm/Group Title LPV/r + RAL LPV/r + NRTIs
Hide Arm/Group Description Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.

Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.

Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.

Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.

Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.

Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.

Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily.

All-Cause Mortality
LPV/r + RAL LPV/r + NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LPV/r + RAL LPV/r + NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   19/258 (7.36%)   30/254 (11.81%) 
Blood and lymphatic system disorders     
Anaemia  1  0/258 (0.00%)  3/254 (1.18%) 
Thrombocytopenia  1  1/258 (0.39%)  0/254 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/258 (0.39%)  0/254 (0.00%) 
Eye disorders     
Toxic optic neuropathy  1  0/258 (0.00%)  1/254 (0.39%) 
Gastrointestinal disorders     
Diarrhoea  1  4/258 (1.55%)  3/254 (1.18%) 
Pancreatitis  1  0/258 (0.00%)  1/254 (0.39%) 
General disorders     
Death  1  0/258 (0.00%)  1/254 (0.39%) 
Pyrexia  1  1/258 (0.39%)  0/254 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/258 (0.39%)  0/254 (0.00%) 
Jaundice cholestatic  1  0/258 (0.00%)  1/254 (0.39%) 
Immune system disorders     
Hypersensitivity  1  0/258 (0.00%)  1/254 (0.39%) 
Infections and infestations     
AIDS dementia complex  1  1/258 (0.39%)  0/254 (0.00%) 
Appendicitis  1  1/258 (0.39%)  0/254 (0.00%) 
Bacterial sepsis  1  1/258 (0.39%)  0/254 (0.00%) 
Dengue fever  1  0/258 (0.00%)  1/254 (0.39%) 
Gastroenteritis  1  0/258 (0.00%)  2/254 (0.79%) 
Influenza  1  0/258 (0.00%)  1/254 (0.39%) 
Leptospirosis  1  1/258 (0.39%)  0/254 (0.00%) 
Lower respiratory tract infection  1  0/258 (0.00%)  1/254 (0.39%) 
Malaria  1  0/258 (0.00%)  1/254 (0.39%) 
Meningitis cryptococcal  1  0/258 (0.00%)  1/254 (0.39%) 
Pelvic inflammatory disease  1  2/258 (0.78%)  0/254 (0.00%) 
Pneumonia  1  0/258 (0.00%)  1/254 (0.39%) 
Pneumonia bacterial  1  1/258 (0.39%)  0/254 (0.00%) 
Progressive multifocal leukoencephalopathy  1  0/258 (0.00%)  1/254 (0.39%) 
Pulmonary tuberculosis  1  1/258 (0.39%)  0/254 (0.00%) 
Tuberculosis gastrointestinal  1  0/258 (0.00%)  1/254 (0.39%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/258 (0.00%)  1/254 (0.39%) 
Lower limb fracture  1  0/258 (0.00%)  1/254 (0.39%) 
Investigations     
Aspartate aminotransferase increased  1  0/258 (0.00%)  1/254 (0.39%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/258 (0.39%)  0/254 (0.00%) 
Hyperlactacidaemia  1  0/258 (0.00%)  1/254 (0.39%) 
Hypertriglyceridaemia  1  3/258 (1.16%)  2/254 (0.79%) 
Hypokalaemia  1  0/258 (0.00%)  1/254 (0.39%) 
Musculoskeletal and connective tissue disorders     
Fasciitis  1  0/258 (0.00%)  1/254 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma  1  0/258 (0.00%)  1/254 (0.39%) 
Kaposi's sarcoma  1  0/258 (0.00%)  1/254 (0.39%) 
Nervous system disorders     
Cerebrovascular accident  1  0/258 (0.00%)  1/254 (0.39%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/258 (0.39%)  0/254 (0.00%) 
Psychiatric disorders     
Depression  1  0/258 (0.00%)  1/254 (0.39%) 
Major depression  1  0/258 (0.00%)  1/254 (0.39%) 
Post-traumatic stress disorder  1  0/258 (0.00%)  1/254 (0.39%) 
Suicide attempt  1  0/258 (0.00%)  1/254 (0.39%) 
Renal and urinary disorders     
Acute kidney injury  1  1/258 (0.39%)  0/254 (0.00%) 
Renal failure  1  0/258 (0.00%)  1/254 (0.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LPV/r + RAL LPV/r + NRTIs
Affected / at Risk (%) Affected / at Risk (%)
Total   252/258 (97.67%)   250/254 (98.43%) 
Gastrointestinal disorders     
Diarrhoea  1  16/258 (6.20%)  25/254 (9.84%) 
Vomiting  1  7/258 (2.71%)  13/254 (5.12%) 
General disorders     
Pyrexia  1  22/258 (8.53%)  23/254 (9.06%) 
Infections and infestations     
Oral candidiasis  1  15/258 (5.81%)  12/254 (4.72%) 
Upper respiratory tract infection  1  19/258 (7.36%)  16/254 (6.30%) 
Urinary tract infection  1  13/258 (5.04%)  13/254 (5.12%) 
Investigations     
Alanine aminotransferase increased  1  55/258 (21.32%)  40/254 (15.75%) 
Aspartate aminotransferase increased  1  70/258 (27.13%)  61/254 (24.02%) 
Blood alkaline phosphatase increased  1  67/258 (25.97%)  73/254 (28.74%) 
Blood bicarbonate decreased  1  79/258 (30.62%)  85/254 (33.46%) 
Blood bilirubin increased  1  27/258 (10.47%)  16/254 (6.30%) 
Blood calcium decreased  1  38/258 (14.73%)  40/254 (15.75%) 
Blood cholesterol increased  1  150/258 (58.14%)  121/254 (47.64%) 
Blood creatinine increased  1  9/258 (3.49%)  17/254 (6.69%) 
Blood glucose decreased  1  15/258 (5.81%)  13/254 (5.12%) 
Blood glucose increased  1  40/258 (15.50%)  36/254 (14.17%) 
Blood phosphorus decreased  1  77/258 (29.84%)  99/254 (38.98%) 
Blood potassium decreased  1  30/258 (11.63%)  41/254 (16.14%) 
Blood sodium decreased  1  149/258 (57.75%)  144/254 (56.69%) 
Blood sodium increased  1  13/258 (5.04%)  8/254 (3.15%) 
Blood triglycerides increased  1  33/258 (12.79%)  26/254 (10.24%) 
Haemoglobin decreased  1  22/258 (8.53%)  22/254 (8.66%) 
Low density lipoprotein increased  1  124/258 (48.06%)  93/254 (36.61%) 
Neutrophil count decreased  1  62/258 (24.03%)  78/254 (30.71%) 
Platelet count decreased  1  24/258 (9.30%)  14/254 (5.51%) 
White blood cell count decreased  1  44/258 (17.05%)  42/254 (16.54%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  33/258 (12.79%)  35/254 (13.78%) 
Nasal congestion  1  13/258 (5.04%)  9/254 (3.54%) 
Oropharyngeal plaque  1  15/258 (5.81%)  10/254 (3.94%) 
Skin and subcutaneous tissue disorders     
Skin lesion  1  13/258 (5.04%)  5/254 (1.97%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications:
[1] Hull M, Moore D, Harris M, et al. A lamivudine (3TC)-based backbone in conjunction with a boosted protease inhibitor (PI) is sufficient to achieve virologic suppression in the presence of M184V mutations. Program and abstracts of the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12-15, 2009; San Francisco, California. Abstract H-916.
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01352715     History of Changes
Other Study ID Numbers: ACTG A5273
1U01AI068636 ( U.S. NIH Grant/Contract )
5UM1AI068634 ( U.S. NIH Grant/Contract )
First Submitted: January 12, 2011
First Posted: May 12, 2011
Results First Submitted: October 29, 2015
Results First Posted: January 6, 2016
Last Update Posted: January 6, 2016