Trial Outcomes & Findings for Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells (NCT NCT01351025)
NCT ID: NCT01351025
Last Updated: 2021-08-03
Results Overview
IL-6 (Interleukin 6) in log10 pg/mL: Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
baseline, week 20, week 24, and week 44
Results posted on
2021-08-03
Participant Flow
A5275 opened under version 1.0 on April 7, 2011, and the first participant was randomized on April 14, 2011. Accrual to the study closed on May 31, 2013, with a total of 98 participants enrolled at 31 sites.
Four enrolled participants did not start study treatment (3 from arm A and 1 from arm B) due to enrollment error and noncompliance. These 4 participants were not included in the study efficacy or safety analyses.
Participant milestones
| Measure |
Arm A: Atorvastatin / Placebo
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Week 0 - 20
STARTED
|
46
|
48
|
|
Week 0 - 20
COMPLETED
|
43
|
47
|
|
Week 0 - 20
NOT COMPLETED
|
3
|
1
|
|
Week 20 - 24
STARTED
|
43
|
47
|
|
Week 20 - 24
COMPLETED
|
43
|
47
|
|
Week 20 - 24
NOT COMPLETED
|
0
|
0
|
|
Week 24 - 44
STARTED
|
43
|
47
|
|
Week 24 - 44
COMPLETED
|
42
|
43
|
|
Week 24 - 44
NOT COMPLETED
|
1
|
4
|
|
Week 44 - 48
STARTED
|
42
|
43
|
|
Week 44 - 48
COMPLETED
|
42
|
43
|
|
Week 44 - 48
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Atorvastatin / Placebo
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Week 0 - 20
Lost to Follow-up
|
2
|
1
|
|
Week 0 - 20
Withdrawal by Subject
|
1
|
0
|
|
Week 24 - 44
Lost to Follow-up
|
0
|
2
|
|
Week 24 - 44
Site closed
|
0
|
1
|
|
Week 24 - 44
unable to get to clinic
|
1
|
1
|
Baseline Characteristics
Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells
Baseline characteristics by cohort
| Measure |
Arm A: Atorvastatin / Placebo
n=46 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=48 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
50 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Age, Customized
18-29 Years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Customized
30-39 Years
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
40-49 Years
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Age, Customized
50-59 Years
|
14 participants
n=5 Participants
|
21 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Age, Customized
>=60 Years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (regardless of race)
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
HIV-1 RNA
< assay lower limit
|
46 participants
n=5 Participants
|
47 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
HIV-1 RNA
>= assay lower limit
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
CD4 count
|
587 cells/mm^3
n=5 Participants
|
545 cells/mm^3
n=7 Participants
|
552 cells/mm^3
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
IL-6 (Interleukin 6) in log10 pg/mL: Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 IL-6
|
-0.08 log10 pg/mL
Interval -0.32 to 0.22
|
-0.08 log10 pg/mL
Interval -0.28 to 0.12
|
PRIMARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
CD4+ T-cell activation percent (% CD38+/DR+ of CD4+): Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=31 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD4+ T-cell Activation Percent
|
-0.20 percent
Interval -5.0 to 2.2
|
0.60 percent
Interval -2.9 to 2.4
|
PRIMARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
D-dimer in log10 ng/mL: Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 D-dimer
|
-0.02 log10 ng/mL
Interval -0.13 to 0.14
|
0.00 log10 ng/mL
Interval -0.18 to 0.08
|
PRIMARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
CD8+ T-cell activation percent (% CD38+/DR+ of CD8+): Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=31 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD8+ T-cell Activation Percent
|
1.10 percent
Interval -4.4 to 5.8
|
-1.15 percent
Interval -4.9 to 3.9
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in MCP-1 (log10 Transformed)
|
0.03 log10 pg/ml
Interval -0.09 to 0.13
|
-0.04 log10 pg/ml
Interval -0.1 to 0.06
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
IFN-gamma-inducible protein 10 (IP-10 or CXCL10) is a chemokine secreted from cells stimulated with type I and II IFNs and LPS, is also a chemoattractant for activated T cells. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in IP-10 (log10 Transformed)
|
-0.03 log10 pg/ml
Interval -0.1 to 0.14
|
-0.04 log10 pg/ml
Interval -0.09 to 0.06
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
Cluster of differentiation 40 (CD40L) is a costimulatory protein found on antigen presenting cells and is required for their activation. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in CD40L (log10 Transformed)
|
0.01 log10 pg/ml
Interval -0.18 to 0.2
|
-0.03 log10 pg/ml
Interval -0.17 to 0.08
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
Soluble cluster of differentiation 14 (sCD14) is a human gene. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD14 (log10 Transformed)
|
0.00 log10 ng/ml
Interval -0.04 to 0.08
|
0.00 log10 ng/ml
Interval -0.08 to 0.09
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
P-selectin is a protein that in humans encoded by the SELP gene. P-selectin functions as a cell adhesion molecule (CAM) on the surfaces of activated endothelial cells, which line the inner surface of blood vessels, and activated platelets. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in P-selectin (log10 Transformed)
|
0.01 log10 ng/ml
Interval -0.1 to 0.17
|
-0.06 log10 ng/ml
Interval -0.14 to 0.05
|
SECONDARY outcome
Timeframe: baseline, week 20, week 24, and week 44Population: This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption \< 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.
CD163 (Cluster of Differentiation 163) is a protein that in humans encoded by the CD163 gene; and sCD163 is soluble CD163. Difference between \[change from week 24 to week 44\] and change from \[baseline to week 20\] is defined as \[week 44 - week 24\] - \[week 20 - baseline\].
Outcome measures
| Measure |
Arm A: Atorvastatin / Placebo
n=34 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=36 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD163 (log10 Transformed)
|
-0.04 log10 ng/ml
Interval -0.12 to 0.05
|
0.03 log10 ng/ml
Interval -0.06 to 0.15
|
SECONDARY outcome
Timeframe: week 0 to week 24Population: participants who started study treatment
Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT \> 3 X ULN, and adverse events prior to study treatment cross-over (baseline to week 24). 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: Atorvastatin / Placebo
n=46 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=48 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Number of Participants With Safety Endpoints Before Study Treatment Cross-over (Baseline to Week 24)
|
20 participants
|
22 participants
|
SECONDARY outcome
Timeframe: week 24 to week 48Population: participants who crossed over study treatment at week 24
Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT \> 3 X ULN, and adverse events after study treatment cross-over (week 24 to week 48). 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: Atorvastatin / Placebo
n=41 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20
|
Arm B: Placebo / Atorvastatin
n=43 Participants
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
|
|---|---|---|
|
Number of Participants With Safety Endpoints After Study Treatment Cross-over (Week 24 to Week 48)
|
20 participants
|
14 participants
|
Adverse Events
Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)
n=46 participants at risk
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
|
Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)
n=48 participants at risk
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
|
Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)
n=41 participants at risk
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
|
Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)
n=43 participants at risk
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
|
|---|---|---|---|---|
|
General disorders
Chest discomfort
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Infections and infestations
Tooth abscess
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.1%
1/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.1%
1/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Psychiatric disorders
Depression
|
0.00%
0/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.1%
1/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
Other adverse events
| Measure |
Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)
n=46 participants at risk
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
|
Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)
n=48 participants at risk
At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
|
Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)
n=41 participants at risk
At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
|
Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)
n=43 participants at risk
At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
4.3%
2/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
10.4%
5/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
7.3%
3/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Alanine aminotransferase abnormal
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
6.2%
3/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
4/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
6.2%
3/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
7.3%
3/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
4/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.1%
1/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
7.3%
3/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
4/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.1%
1/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.3%
1/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood bicarbonate decreased
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
10.4%
5/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.3%
1/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood bilirubin increased
|
41.3%
19/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
50.0%
24/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
19.5%
8/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
46.5%
20/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood cholesterol increased
|
26.1%
12/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
47.9%
23/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
36.6%
15/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
9.3%
4/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood creatinine increased
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
16.7%
8/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.9%
2/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
16.3%
7/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood glucose decreased
|
8.7%
4/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
10.4%
5/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
7.3%
3/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.7%
2/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood glucose increased
|
6.5%
3/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
18.8%
9/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
17.1%
7/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
14.0%
6/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Blood potassium decreased
|
6.5%
3/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
6.2%
3/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
7.3%
3/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.3%
1/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Low density lipoprotein increased
|
15.2%
7/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
37.5%
18/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
19.5%
8/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Investigations
Platelet count decreased
|
6.5%
3/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.2%
2/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.9%
2/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
3/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.2%
2/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.4%
1/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
2.3%
1/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
9.8%
4/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
9.3%
4/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Nervous system disorders
Headache
|
8.7%
4/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
4.2%
2/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
3/46 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
8.3%
4/48 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/41 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
0.00%
0/43 • Week 0 to week 24 (before cross-over) and week 24 to week 48 (after cross-over)
Wk 0-24 and Wk 24-48 summaries included participants started study rx and participants remained on study rx at wk24, respectively. Protocol required reporting of signs/symptoms/lab values of Gr 2+, events led to a change in study rx, and new diagnoses identified by the ACTG criteria. See DAIDS AE Grading Table v.1, Dec04 (Clarification Aug09).
|
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 In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER