Trial Outcomes & Findings for Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV (NCT NCT00090779)
NCT ID: NCT00090779
Last Updated: 2018-10-11
Results Overview
The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the "failures" who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
TERMINATED
PHASE2
130 participants
At Weeks 72 and 76
2018-10-11
Participant Flow
Participants were recruited across 27 study sites (25 in the US and 2 in Peru) in the AIDS Clinical Trials Group system between February 2005 and June 2009.
Participant milestones
| Measure |
IT Arm
On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
|
DT Arm
On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
|
|---|---|---|
|
Step 1
STARTED
|
66
|
64
|
|
Step 1
COMPLETED
|
55
|
49
|
|
Step 1
NOT COMPLETED
|
11
|
15
|
|
Step 2
STARTED
|
6
|
19
|
|
Step 2
COMPLETED
|
0
|
1
|
|
Step 2
NOT COMPLETED
|
6
|
18
|
|
Step 3
STARTED
|
7
|
5
|
|
Step 3
COMPLETED
|
0
|
0
|
|
Step 3
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
IT Arm
On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
|
DT Arm
On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
|
|---|---|---|
|
Step 1
Withdrawal by Subject
|
4
|
2
|
|
Step 1
Lost to Follow-up
|
3
|
2
|
|
Step 1
Death
|
0
|
2
|
|
Step 1
Physician Decision
|
1
|
0
|
|
Step 1
Pregnancy
|
1
|
0
|
|
Step 1
Non-compliance to study requirements
|
0
|
1
|
|
Step 1
Subject relocated
|
2
|
8
|
|
Step 2
Off study per study closure
|
6
|
16
|
|
Step 2
Subject relocated
|
0
|
1
|
|
Step 2
Non-compliance to study requirements
|
0
|
1
|
|
Step 3
Initiation of ART and off extended study
|
3
|
2
|
|
Step 3
Off extended study due to study closure
|
4
|
3
|
Baseline Characteristics
Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV
Baseline characteristics by cohort
| Measure |
IT Arm
n=66 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race
White
|
49 participants
n=5 Participants
|
56 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Race
Black/ African American
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race
Other
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Age, Customized
<20 years
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race
Unknown
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
52 participants
n=5 Participants
|
55 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
CD4 Counts
|
570 cells/mm3
STANDARD_DEVIATION 197 • n=5 Participants
|
611 cells/mm3
STANDARD_DEVIATION 207 • n=7 Participants
|
590 cells/mm3
STANDARD_DEVIATION 202 • n=5 Participants
|
|
CD4 Count Category
201-350 cells/mm^3
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
CD4 Count Category
351-500 cells/mm^3
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
CD4 Count Category
>500 cells/mm^3
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Log10 HIV-1 RNA Viral Load
|
4.4 log10 copies/mL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 log10 copies/mL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.4 log10 copies/mL
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
HIV-1 RNA Viral Load Category
200-399 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HIV-1 RNA Viral Load Category
400-999 copies/mL
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HIV-1 RNA Viral Load Category
1000-9999 copies/mL
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
HIV-1 RNA Viral Load Category
>=10000 copies/mL
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Weeks 72 and 76Population: Participants in follow-up at least 72 weeks since randomization were included.
The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the "failures" who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
Outcome measures
| Measure |
IT Arm
n=39 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=40 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm
|
26.0 rank
Interval 1.0 to 70.0
|
49.3 rank
Interval 4.0 to 70.0
|
PRIMARY outcome
Timeframe: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)Population: Participants in follow-up at least 72 weeks since randomization were included.
The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the "failures" who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.
Outcome measures
| Measure |
IT Arm
n=39 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=40 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm
|
26.0 rank
Interval 1.0 to 70.0
|
48.5 rank
Interval 28.0 to 67.5
|
PRIMARY outcome
Timeframe: 96 weeks since randomizationOutcome measures
| Measure |
IT Arm
n=66 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)Population: One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.
Outcome measures
| Measure |
IT Arm
n=65 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
IT arm (wk 84- wk 36) vs. DT arm (wk 48- wk 0)
|
-0.10 Change in Log10 transformed CD4 Counts
Standard Deviation 0.12
|
-0.06 Change in Log10 transformed CD4 Counts
Standard Deviation 0.17
|
|
Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
IT arm (wk 60- wk 36) vs. DT arm (wk 24- wk 0)
|
-0.11 Change in Log10 transformed CD4 Counts
Standard Deviation 0.10
|
-0.02 Change in Log10 transformed CD4 Counts
Standard Deviation 0.12
|
|
Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
IT arm (wk 72- wk 36) vs. DT arm (wk 36- wk 0)
|
-0.10 Change in Log10 transformed CD4 Counts
Standard Deviation 0.12
|
-0.03 Change in Log10 transformed CD4 Counts
Standard Deviation 0.11
|
|
Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
IT arm (wk 96- wk 36) vs. DT arm (wk 60- wk 0)
|
-0.12 Change in Log10 transformed CD4 Counts
Standard Deviation 0.13
|
-0.02 Change in Log10 transformed CD4 Counts
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 96 weeks since randomizationPopulation: All 130 eligible subjects were included.
The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm\^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm\^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.
Outcome measures
| Measure |
IT Arm
n=66 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
|
7 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At Week 36Population: All 66 eligible subjects in IT arm were included.
The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.
Outcome measures
| Measure |
IT Arm
n=66 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
DT arm participants received no Treatment
|
|---|---|---|
|
Number of Participants in IT Arm Off Treatment Before 36 Weeks
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: 96 weeks since randomizationPopulation: Throughout database cutoff for DSMB review (by July 2, 2009).
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm\^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm\^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.
Outcome measures
| Measure |
IT Arm
n=65 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
5th percentile
|
6.3 weeks
Interval 0.0 to 13.0
|
6.9 weeks
Interval 2.3 to 12.3
|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
10th percentile
|
13.0 weeks
Interval 0.0 to 26.1
|
12.3 weeks
Interval 2.3 to 18.3
|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
25th percentile
|
36.4 weeks
Interval 19.9 to 50.4
|
26.3 weeks
Interval 16.9 to 36.4
|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
50th percentile
|
72.0 weeks
Interval 52.4 to 94.1
|
60.0 weeks
Interval 36.4 to 93.9
|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
75th percentile
|
NA weeks
Not estimable as the estimates for survival function at all weeks is above 25%
|
96.0 weeks
Interval 72.0 to 96.0
|
|
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
90th percentile
|
NA weeks
Not estimable as the estimates for survival function at all weeks is above 10%
|
96.0 weeks
Interval 96.0 to
Not estimable as the upper limit for survival function at all weeks is above 10%
|
SECONDARY outcome
Timeframe: 96 weeks since randomizationPopulation: Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm\^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm\^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.
Outcome measures
| Measure |
IT Arm
n=65 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
25th percentile
|
22.7 weeks
Interval 13.0 to 39.3
|
26.3 weeks
Interval 16.9 to 36.4
|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
5th percentile
|
5.1 weeks
Interval 0.4 to 13.0
|
6.9 weeks
Interval 2.3 to 12.3
|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
10th percentile
|
10.4 weeks
Interval 0.4 to 16.4
|
12.3 weeks
Interval 2.3 to 18.3
|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
50th percentile
|
58.1 weeks
Interval 36.0 to
Not estimable as the upper limit for survival function at all weeks is above 50%
|
60.0 weeks
Interval 36.4 to 93.9
|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
75th percentile
|
NA weeks
Not estimable as the estimates for survival function at all weeks is above 25%
|
96.0 weeks
Interval 72.0 to 96.0
|
|
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
90th percentile
|
NA weeks
Not estimable as the estimates for survival function at all weeks is above 10%
|
96.0 weeks
Interval 96.0 to
Not estimable as the upper limit for survival function at all weeks is above 10%
|
SECONDARY outcome
Timeframe: 5 years since randomizationPopulation: All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.
5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death
Outcome measures
| Measure |
IT Arm
n=65 Participants
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 Participants
DT arm participants received no Treatment
|
|---|---|---|
|
Time to Treatment Initiation or Death
5th percentile
|
36 weeks
Interval 0.0 to 36.9
|
13.9 weeks
Interval 6.4 to 20.9
|
|
Time to Treatment Initiation or Death
10th percentile
|
36.9 weeks
Interval 0.0 to 51.9
|
20.9 weeks
Interval 6.4 to 37.0
|
|
Time to Treatment Initiation or Death
25th percentile
|
67.1 weeks
Interval 44.0 to 94.6
|
43.7 weeks
Interval 31.6 to 96.0
|
|
Time to Treatment Initiation or Death
50th percentile
|
96.4 weeks
Interval 94.0 to 157.9
|
97.3 weeks
Interval 94.0 to 146.4
|
|
Time to Treatment Initiation or Death
75th percentile
|
163.3 weeks
Interval 97.7 to
Not estimable as the upper limit for survival function at all weeks is above 25%
|
157.7 weeks
Interval 99.9 to
Not estimable as the upper limit for survival function at all weeks is above 25%
|
Adverse Events
IT Arm
DT Arm
Serious adverse events
| Measure |
IT Arm
n=66 participants at risk
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 participants at risk
DT arm participants received no Treatment
|
|---|---|---|
|
Investigations
Blood bilirubin increased
|
1.5%
1/66 • 5 years since randomization
|
0.00%
0/64 • 5 years since randomization
|
Other adverse events
| Measure |
IT Arm
n=66 participants at risk
IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
|
DT Arm
n=64 participants at risk
DT arm participants received no Treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
1/66 • 5 years since randomization
|
7.8%
5/64 • 5 years since randomization
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
Gastrointestinal disorders
Diarrhoea
|
28.8%
19/66 • 5 years since randomization
|
15.6%
10/64 • 5 years since randomization
|
|
Gastrointestinal disorders
Nausea
|
12.1%
8/66 • 5 years since randomization
|
9.4%
6/64 • 5 years since randomization
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
5/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
General disorders
Fatigue
|
13.6%
9/66 • 5 years since randomization
|
9.4%
6/64 • 5 years since randomization
|
|
General disorders
Pyrexia
|
7.6%
5/66 • 5 years since randomization
|
4.7%
3/64 • 5 years since randomization
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
6/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
10/66 • 5 years since randomization
|
23.4%
15/64 • 5 years since randomization
|
|
Investigations
Aspartate aminotransferase increased
|
12.1%
8/66 • 5 years since randomization
|
18.8%
12/64 • 5 years since randomization
|
|
Investigations
Blood bilirubin increased
|
10.6%
7/66 • 5 years since randomization
|
4.7%
3/64 • 5 years since randomization
|
|
Investigations
Blood cholesterol abnormal
|
22.7%
15/66 • 5 years since randomization
|
18.8%
12/64 • 5 years since randomization
|
|
Investigations
Blood cholesterol increased
|
19.7%
13/66 • 5 years since randomization
|
15.6%
10/64 • 5 years since randomization
|
|
Investigations
Blood glucose abnormal
|
13.6%
9/66 • 5 years since randomization
|
15.6%
10/64 • 5 years since randomization
|
|
Investigations
Blood glucose decreased
|
10.6%
7/66 • 5 years since randomization
|
7.8%
5/64 • 5 years since randomization
|
|
Investigations
Blood phosphorus decreased
|
33.3%
22/66 • 5 years since randomization
|
18.8%
12/64 • 5 years since randomization
|
|
Investigations
Blood triglycerides abnormal
|
6.1%
4/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
Investigations
Blood uric acid increased
|
7.6%
5/66 • 5 years since randomization
|
3.1%
2/64 • 5 years since randomization
|
|
Investigations
Lipase increased
|
9.1%
6/66 • 5 years since randomization
|
20.3%
13/64 • 5 years since randomization
|
|
Investigations
Low density lipoprotein
|
4.5%
3/66 • 5 years since randomization
|
7.8%
5/64 • 5 years since randomization
|
|
Investigations
Low density lipoprotein abnormal
|
22.7%
15/66 • 5 years since randomization
|
26.6%
17/64 • 5 years since randomization
|
|
Investigations
Low density lipoprotein increased
|
13.6%
9/66 • 5 years since randomization
|
4.7%
3/64 • 5 years since randomization
|
|
Investigations
Neutrophil count decreased
|
9.1%
6/66 • 5 years since randomization
|
9.4%
6/64 • 5 years since randomization
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
Nervous system disorders
Dizziness
|
6.1%
4/66 • 5 years since randomization
|
3.1%
2/64 • 5 years since randomization
|
|
Nervous system disorders
Headache
|
6.1%
4/66 • 5 years since randomization
|
7.8%
5/64 • 5 years since randomization
|
|
Nervous system disorders
Migraine
|
6.1%
4/66 • 5 years since randomization
|
0.00%
0/64 • 5 years since randomization
|
|
Psychiatric disorders
Depression
|
9.1%
6/66 • 5 years since randomization
|
9.4%
6/64 • 5 years since randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.6%
5/66 • 5 years since randomization
|
3.1%
2/64 • 5 years since randomization
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.5%
1/66 • 5 years since randomization
|
6.2%
4/64 • 5 years since randomization
|
|
Vascular disorders
Hypertension
|
6.1%
4/66 • 5 years since randomization
|
3.1%
2/64 • 5 years since randomization
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
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