Trial Outcomes & Findings for Study of Options for Second-Line Effective Combination Therapy (SELECT) (NCT NCT01352715)
NCT ID: NCT01352715
Last Updated: 2021-08-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
515 participants
Primary outcome timeframe
From study entry to week 48
Results posted on
2021-08-05
Participant Flow
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).
515 were randomized 1:1 to treatment arms A and B.
Participant milestones
| Measure |
Arm A: LPV/r Plus RAL
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.
|
Arm B: LPV/r Plus Best Available NRTIs
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 Study
STARTED
|
260
|
255
|
|
Overall Study
COMPLETED
|
215
|
209
|
|
Overall Study
NOT COMPLETED
|
45
|
46
|
Reasons for withdrawal
| Measure |
Arm A: LPV/r Plus RAL
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.
|
Arm B: LPV/r Plus Best Available NRTIs
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 Study
Death
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
|
Overall Study
site closure
|
16
|
15
|
|
Overall Study
no final visit in closeout period
|
15
|
12
|
|
Overall Study
major ineligibility
|
2
|
1
|
Baseline Characteristics
Study of Options for Second-Line Effective Combination Therapy (SELECT)
Baseline characteristics by cohort
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
258 Participants
n=99 Participants
|
254 Participants
n=107 Participants
|
512 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 8 • n=99 Participants
|
38 years
STANDARD_DEVIATION 8 • n=107 Participants
|
39 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
164 participants
n=99 Participants
|
162 participants
n=107 Participants
|
326 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
11 participants
n=99 Participants
|
9 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
83 participants
n=99 Participants
|
82 participants
n=107 Participants
|
165 participants
n=206 Participants
|
|
Region of Enrollment
Malawi
|
56 participants
n=99 Participants
|
55 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
52 participants
n=99 Participants
|
51 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Region of Enrollment
India
|
80 participants
n=99 Participants
|
78 participants
n=107 Participants
|
158 participants
n=206 Participants
|
|
Region of Enrollment
Zimbabwe
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
Tanzania
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
HIV-1 RNA
|
4.6 log10 copies/mL
STANDARD_DEVIATION 0.8 • n=99 Participants
|
4.5 log10 copies/mL
STANDARD_DEVIATION 0.9 • n=107 Participants
|
4.5 log10 copies/mL
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
CD4+ T-cell count
|
178 cells/mm^3
STANDARD_DEVIATION 170 • n=99 Participants
|
182 cells/mm^3
STANDARD_DEVIATION 160 • n=107 Participants
|
180 cells/mm^3
STANDARD_DEVIATION 165 • n=206 Participants
|
PRIMARY outcome
Timeframe: From study entry to week 48Population: Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.
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.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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.
|
|---|---|---|
|
Cumulative Probability of Virologic Failure by Week 48
|
10.3 cumulative probability per 100 persons
Interval 6.5 to 14.0
|
12.4 cumulative probability per 100 persons
Interval 8.3 to 16.5
|
SECONDARY outcome
Timeframe: Study entry and week 48Population: 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.
Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=246 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=242 Participants
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.
|
|---|---|---|
|
Change in CD4+ Cell Count From Baseline to Week 48
|
199 cells/mm^3
Interval 181.0 to 218.0
|
190 cells/mm^3
Interval 171.0 to 209.0
|
SECONDARY outcome
Timeframe: From study entry through to week 96Population: Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.
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.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=39 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=45 Participants
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.
|
|---|---|---|
|
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
No new IAS mutations
|
29 participants
|
32 participants
|
|
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
1-2 new IAS mutations
|
9 participants
|
13 participants
|
|
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
3 new IAS mutations
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)Population: As treated: Participants on randomized treatment are included in this analysis.
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=253 Participants
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.
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
|
62 participants
|
81 participants
|
SECONDARY outcome
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)Population: 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.
Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=253 Participants
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.
|
|---|---|---|
|
Number of Participants Discontinuing Randomized Treatment for Toxicity
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From study entry throughout follow-up (up to 96 weeks)Population: Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.
AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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.
|
|---|---|---|
|
Number of Participants With a New AIDS-defining Events or Death
|
15 participants
|
17 participants
|
SECONDARY outcome
Timeframe: From study entry throughout follow-up (up to 96 weeks)Population: Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.
Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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.
|
|---|---|---|
|
Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
|
7 participants
|
7 participants
|
SECONDARY outcome
Timeframe: From study entry throughout follow-up (up to 96 weeks)Population: Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.
The percentage of total study time that participants were in hospital.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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.
|
|---|---|---|
|
Percentage of Time Spent in Hospital
|
0.08 percentage of time spent in hospital
|
0.12 percentage of time spent in hospital
|
SECONDARY outcome
Timeframe: Study entry and week 48Population: 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)
Fasting was for 8 hours and the metabolic panel was drawn locally.
Outcome measures
| Measure |
Arm A: LPV/r Plus RAL
n=258 Participants
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.
|
Arm B: LPV/r Plus Best Available NRTIs
n=254 Participants
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.
|
|---|---|---|
|
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
glucose change
|
2 mg/dL
Interval 0.0 to 5.0
|
3 mg/dL
Interval 2.0 to 5.0
|
|
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
total cholesterol change
|
31 mg/dL
Interval 24.0 to 38.0
|
15 mg/dL
Interval 9.0 to 20.0
|
|
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
high-density lipoprotein (HDL) cholesterol change
|
4 mg/dL
Interval 2.0 to 6.0
|
2 mg/dL
Interval 0.0 to 4.0
|
|
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
low-density lipoprotein (LDL) cholesterol change
|
17 mg/dL
Interval 12.0 to 21.0
|
10 mg/dL
Interval 6.0 to 15.0
|
|
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
triglycerides change
|
80 mg/dL
Interval 51.0 to 109.0
|
31 mg/dL
Interval 13.0 to 49.0
|
Adverse Events
LPV/r + RAL
Serious events: 19 serious events
Other events: 252 other events
Deaths: 0 deaths
LPV/r + NRTIs
Serious events: 30 serious events
Other events: 250 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LPV/r + RAL
n=258 participants at risk
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.
|
LPV/r + NRTIs
n=254 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
1.2%
3/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Eye disorders
Toxic optic neuropathy
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
4/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
1.2%
3/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
General disorders
Death
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
General disorders
Pyrexia
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
AIDS dementia complex
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Appendicitis
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Bacterial sepsis
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.79%
2/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Leptospirosis
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Malaria
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.78%
2/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Tuberculosis gastrointestinal
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.2%
3/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.79%
2/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.00%
0/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
0.39%
1/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
Other adverse events
| Measure |
LPV/r + RAL
n=258 participants at risk
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.
|
LPV/r + NRTIs
n=254 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
16/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
9.8%
25/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
7/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
5.1%
13/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
General disorders
Pyrexia
|
8.5%
22/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
9.1%
23/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Oral candidiasis
|
5.8%
15/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
4.7%
12/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
19/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
6.3%
16/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
13/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
5.1%
13/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Alanine aminotransferase increased
|
21.3%
55/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
15.7%
40/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Aspartate aminotransferase increased
|
27.1%
70/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
24.0%
61/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
26.0%
67/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
28.7%
73/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood bicarbonate decreased
|
30.6%
79/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
33.5%
85/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood bilirubin increased
|
10.5%
27/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
6.3%
16/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood calcium decreased
|
14.7%
38/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
15.7%
40/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood cholesterol increased
|
58.1%
150/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
47.6%
121/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood creatinine increased
|
3.5%
9/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
6.7%
17/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood glucose decreased
|
5.8%
15/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
5.1%
13/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood glucose increased
|
15.5%
40/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
14.2%
36/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood phosphorus decreased
|
29.8%
77/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
39.0%
99/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood potassium decreased
|
11.6%
30/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
16.1%
41/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood sodium decreased
|
57.8%
149/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
56.7%
144/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood sodium increased
|
5.0%
13/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
3.1%
8/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Blood triglycerides increased
|
12.8%
33/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
10.2%
26/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Haemoglobin decreased
|
8.5%
22/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
8.7%
22/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Low density lipoprotein increased
|
48.1%
124/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
36.6%
93/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Neutrophil count decreased
|
24.0%
62/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
30.7%
78/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
Platelet count decreased
|
9.3%
24/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
5.5%
14/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Investigations
White blood cell count decreased
|
17.1%
44/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
16.5%
42/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
33/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
13.8%
35/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
13/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
3.5%
9/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
5.8%
15/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
3.9%
10/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
13/258 • From study entry throughout follow-up (up to 96 weeks)
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.
|
2.0%
5/254 • From study entry throughout follow-up (up to 96 weeks)
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.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place