Trial Outcomes & Findings for IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children (NCT NCT01818258)
NCT ID: NCT01818258
Last Updated: 2021-08-12
Results Overview
Number (percent) of participants with at least one grade 3 or higher adverse event (AE) regardless of the relationship to study drugs.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
From week 0 to week 24
Results posted on
2021-08-12
Participant Flow
A total of 52 participants, 25 in the Severe Acute Malnutrition (SAM) cohort and 27 in the non-SAM cohort, enrolled over a period of 12 months between October 26, 2015 and October 21, 2016. The SAM cohort was slower to enroll. Participants were enrolled from 5 sites in 4 African countries: Malawi, Tanzania, Uganda, and Zimbabwe.
Children with severe acute malnutrition (SAM) during the screening period were enrolled into the study 10-18 days after starting nutritional rehabilitation, and were required to show clinical improvement. SAM/non-SAM cohort assignments were determined during screening.
Participant milestones
| Measure |
Severe Malnutrition Cohort
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Severe Malnutrition Cohort
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Unable to Travel to Clinic
|
0
|
1
|
Baseline Characteristics
IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Baseline characteristics by cohort
| Measure |
Severe Malnutrition Cohort
n=25 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=27 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.4 months
STANDARD_DEVIATION 8.0 • n=5 Participants
|
19.1 months
STANDARD_DEVIATION 8.5 • n=7 Participants
|
19.2 months
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Tanzania
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Zimbabwe
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
World Health Organization (WHO) Weight-for-Height Z-Score
|
-3.4 Z-Score
STANDARD_DEVIATION 0.8 • n=5 Participants
|
-0.7 Z-Score
STANDARD_DEVIATION 1.2 • n=7 Participants
|
-2.0 Z-Score
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Mid-Upper Arm Circumference
|
11.1 centimeters
STANDARD_DEVIATION 1.1 • n=5 Participants
|
14.2 centimeters
STANDARD_DEVIATION 1.6 • n=7 Participants
|
12.7 centimeters
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Log10 Plasma HIV RNA Viral Load
|
4.8 log 10 copies/mL
STANDARD_DEVIATION 1.2 • n=5 Participants
|
5.2 log 10 copies/mL
STANDARD_DEVIATION 1.3 • n=7 Participants
|
5.0 log 10 copies/mL
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
CD4 Percent
|
15.5 percent
STANDARD_DEVIATION 8.8 • n=5 Participants
|
24.5 percent
STANDARD_DEVIATION 11.3 • n=7 Participants
|
20.2 percent
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Nutritional Cohort Subgroup
Severe Malnutrition
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Nutritional Cohort Subgroup
Mild Malnutrition
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Nutritional Cohort Subgroup
Normal Nutrition
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From week 0 to week 24Population: All participants who received at least one dose of study treatment (ZDV, 3TC, and LPV/r)
Number (percent) of participants with at least one grade 3 or higher adverse event (AE) regardless of the relationship to study drugs.
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=25 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=27 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Grade 3 or Higher Adverse Events Through 24 Weeks
|
13 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: From week 0 to week 24Population: All participants who received at least one dose of study treatment (ZDV, 3TC, and LPV/r)
Number (percent) of participants with at least one Grade 3 or higher adverse event related to study drugs
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=25 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=27 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Grade 3 or Higher Adverse Events Related to Study Drugs Through Week 24
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with LPV AUC data at week 1 and at week 12 or 24
Steady-state area under the curve (AUC) for Lopinavir (LPV)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=22 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=23 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Steady-state Lopinavir Area Under the Curve
Week 1
|
49.8 ug*hours/mL
Interval 28.5 to 87.2
|
64.8 ug*hours/mL
Interval 37.6 to 111.9
|
|
Steady-state Lopinavir Area Under the Curve
Week 12
|
53.0 ug*hours/mL
Interval 26.1 to 107.5
|
83.4 ug*hours/mL
Interval 60.4 to 115.0
|
|
Steady-state Lopinavir Area Under the Curve
Week 24
|
64.6 ug*hours/mL
Interval 28.3 to 147.5
|
79.4 ug*hours/mL
Interval 56.8 to 111.0
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with LPV CL/F data at week 1 and at week 12 or 24
Steady-state plasma clearance (CL/F) of LPV
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=22 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=23 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Plasma Clearance of Lopinavir
LPV CL/F at Week 1
|
2.2 L/hours
Interval 1.2 to 3.9
|
2.0 L/hours
Interval 1.2 to 3.5
|
|
Plasma Clearance of Lopinavir
LPV CL/F at Week 12
|
2.3 L/hours
Interval 1.1 to 4.7
|
1.6 L/hours
Interval 1.2 to 2.3
|
|
Plasma Clearance of Lopinavir
LPV CL/F at Week 24
|
2.1 L/hours
Interval 0.9 to 4.8
|
1.7 L/hours
Interval 1.2 to 2.5
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with RTV AUC data at week 1 and at week 12 or 24
Steady-state area under the curve (AUC) for Ritonavir (RTV)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=22 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=23 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Steady-state Ritonavir Area Under the Curve
RTV AUC Week 24
|
2.3 ug*hours/mL
Interval 1.3 to 4.3
|
3.0 ug*hours/mL
Interval 2.2 to 4.0
|
|
Steady-state Ritonavir Area Under the Curve
RTV AUC Week 1
|
1.6 ug*hours/mL
Interval 1.0 to 2.5
|
2.1 ug*hours/mL
Interval 1.2 to 3.6
|
|
Steady-state Ritonavir Area Under the Curve
RTV AUC Week 12
|
1.8 ug*hours/mL
Interval 1.0 to 3.1
|
3.0 ug*hours/mL
Interval 2.1 to 4.5
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with RTV CL/F data at week 1 and at week 12 or 24
Steady-state plasma clearance (CL/F) of RTV
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=22 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=23 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Plasma Clearance of Ritonavir
RTV CL/F at Week 12
|
17.3 L/hours
Interval 9.6 to 31.0
|
11.2 L/hours
Interval 7.6 to 16.6
|
|
Plasma Clearance of Ritonavir
RTV CL/F at Week 24
|
14.8 L/hours
Interval 8.1 to 27.2
|
11.5 L/hours
Interval 8.4 to 15.7
|
|
Plasma Clearance of Ritonavir
RTV CL/F at Week 1
|
16.9 L/hours
Interval 10.5 to 27.2
|
15.8 L/hours
Interval 9.2 to 27.2
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with 3TC AUC data at week 1 and at week 12 or 24
Steady-state area under the curve (AUC) of Lamivudine (3TC)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=21 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=21 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Steady-state Lamivudine Area Under the Curve
3TC AUC at Week 1
|
4,245.0 ng*hours/mL
|
5,520.2 ng*hours/mL
|
|
Steady-state Lamivudine Area Under the Curve
3TC AUC at Week 12
|
4,365.5 ng*hours/mL
|
7,233.0 ng*hours/mL
|
|
Steady-state Lamivudine Area Under the Curve
3TC AUC at Week 24
|
6,359.0 ng*hours/mL
|
5,849.2 ng*hours/mL
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with 3TC CL/F data at week 1 and at week 12 or 24
Steady-state plasma clearance (CL/F) of Lamivudine (3TC)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=21 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=21 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Plasma Clearance of Lamivudine
3TC CL/F at Week 1
|
8.7 L/hours
Interval 6.0 to 12.7
|
8.4 L/hours
Interval 6.2 to 11.5
|
|
Plasma Clearance of Lamivudine
3TC CL/F at Week 12
|
9.5 L/hours
Interval 5.9 to 15.4
|
6.8 L/hours
Interval 5.7 to 8.1
|
|
Plasma Clearance of Lamivudine
3TC CL/F at Week 24
|
7.5 L/hours
Interval 6.2 to 9.0
|
8.8 L/hours
Interval 5.3 to 14.7
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with ZDV AUC data at week 1 and at week 12 or 24
Steady-state area under the curve (AUC) of zidovudine (ZDV)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=15 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=16 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Steady-state Zidovudine Area Under the Curve
ZDV AUC at Week 1
|
2,261.0 ng*hours/mL
|
1,774.0 ng*hours/mL
|
|
Steady-state Zidovudine Area Under the Curve
ZDV AUC at Week 12
|
1,826.0 ng*hours/mL
Interval 977.8 to
|
1,335.7 ng*hours/mL
Interval 758.5 to
|
|
Steady-state Zidovudine Area Under the Curve
ZDV AUC at Week 24
|
2,449.7 ng*hours/mL
|
1,609.3 ng*hours/mL
|
PRIMARY outcome
Timeframe: 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 12, and 24 weeks following study entryPopulation: Participants with ZDV CL/F data at week 1 and at week 12 or 24
Steady-state plasma clearance (CL/F) of Zidovudine (ZDV)
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=15 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=16 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Plasma Clearance of Zidovudine
ZDV CL/F at Week 1
|
34.8 L/hours
Interval 24.4 to 49.5
|
58.3 L/hours
Interval 34.8 to 97.9
|
|
Plasma Clearance of Zidovudine
ZDV CL/F at Week 12
|
48.8 L/hours
Interval 24.8 to 95.8
|
81.8 L/hours
Interval 44.9 to 148.9
|
|
Plasma Clearance of Zidovudine
ZDV CL/F at Week 24
|
40.8 L/hours
Interval 33.0 to 50.4
|
64.0 L/hours
Interval 51.7 to 79.1
|
SECONDARY outcome
Timeframe: Measured 0, 1, 2, 4, 8, and 12 hours post-dose on 1, 4, 8, 12, 16, 24, 36 and 48 weeks following study entryPopulation: Participants with minimum trough concentration of LPV data
Count (%) of participants with minimum trough concentration (Ctrough) of steady-state Lopinavir \>= 1 ug/mL
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=24 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=25 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 1
|
12 Participants
|
21 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 4
|
14 Participants
|
18 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 8
|
13 Participants
|
18 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 12
|
17 Participants
|
18 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 16
|
11 Participants
|
15 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 24
|
14 Participants
|
19 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 36
|
16 Participants
|
19 Participants
|
|
Minimum Trough Concentration (Ctrough) of Lopinavir
Week 48
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 12 and 24Population: Participants with LPV free fraction data available
Free fraction of steady-state lopinavir at 2 hours post dose
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=9 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=14 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Free Fraction of LPV at Hour 2 Post Dose
Week 1
|
0.8 Percent of Unbound LPV
Standard Deviation 0.8
|
3.2 Percent of Unbound LPV
Standard Deviation 2.3
|
|
Free Fraction of LPV at Hour 2 Post Dose
Week 12
|
2.2 Percent of Unbound LPV
Standard Deviation 1.0
|
6.0 Percent of Unbound LPV
Standard Deviation 3.8
|
|
Free Fraction of LPV at Hour 2 Post Dose
Week 24
|
3.1 Percent of Unbound LPV
Standard Deviation 2.8
|
2.1 Percent of Unbound LPV
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Weeks 0, 12, 24, 36 and 48Population: Participants with data at baseline and timepoint of interest (week 12, 24, 36, or 48)
Change from baseline in plasma HIV RNA viral load
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=22 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=23 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Change in HIV Viral Load From Baseline
Change in Log10 Viral Load between Baseline and Week 12
|
-1.4 log10 copies/mL
Interval -2.1 to -0.7
|
-2.1 log10 copies/mL
Interval -2.8 to -1.4
|
|
Change in HIV Viral Load From Baseline
Change in Log10 Viral Load between Baseline and Week 24
|
-1.7 log10 copies/mL
Interval -2.6 to -0.9
|
-2.5 log10 copies/mL
Interval -3.3 to -1.7
|
|
Change in HIV Viral Load From Baseline
Change in Log10 Viral Load between Baseline and Week 36
|
-1.8 log10 copies/mL
Interval -2.5 to -1.0
|
-2.5 log10 copies/mL
Interval -3.2 to -1.8
|
|
Change in HIV Viral Load From Baseline
Change in Log10 Viral Load between Baseline and Week 48
|
-1.8 log10 copies/mL
Interval -2.5 to -1.1
|
-2.6 log10 copies/mL
Interval -3.4 to -1.9
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 24, and 48Population: Participants with data at baseline and timepoint of interest (week 12, 24, or 48)
Count (%) of participants with plasma HIV RNA viral load \<400 copies/mL
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=25 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=27 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
HIV Viral Load <400 Copies/mL
Week 12
|
8 Participants
|
14 Participants
|
|
HIV Viral Load <400 Copies/mL
Week 24
|
11 Participants
|
18 Participants
|
|
HIV Viral Load <400 Copies/mL
Baseline
|
2 Participants
|
2 Participants
|
|
HIV Viral Load <400 Copies/mL
Week 48
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 12, 24, 36 and 48Population: Participants with CD4 percent data at baseline and timepoint of interest (week 12, 24, 36, or 48)
Change in CD4 percent from baseline
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=23 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=24 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Change in CD4 Percent
Change in CD4 Percent at Week 12
|
3.3 percent
Interval 0.0 to 6.5
|
3.0 percent
Interval 0.2 to 5.8
|
|
Change in CD4 Percent
Change in CD4 Percent at Week 24
|
9.3 percent
Interval 5.0 to 13.7
|
6.8 percent
Interval 4.0 to 9.6
|
|
Change in CD4 Percent
Change in CD4 Percent at Week 36
|
10.3 percent
Interval 6.1 to 14.4
|
7.1 percent
Interval 4.7 to 9.5
|
|
Change in CD4 Percent
Change in CD4 Percent at Week 48
|
12.7 percent
Interval 8.3 to 17.1
|
6.7 percent
Interval 4.2 to 9.1
|
SECONDARY outcome
Timeframe: Weeks 0, 24, and 48Population: Participants with weight and height data available
Change in WHO weight-for-height Z-score from entry. A Z-score indicates the number of standard deviations the measurement is away from the mean. A Z-score of 0 is equal to the mean of the reference population. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. The reference population was determined by the World Health Organization for children from 0 up to 5 years.
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=25 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=27 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Change in WHO Weight-for-height Z-score
Week 24
|
2.3 Z-Score
Interval 1.8 to 2.9
|
0.1 Z-Score
Interval -0.3 to 0.5
|
|
Change in WHO Weight-for-height Z-score
Week 48
|
2.7 Z-Score
Interval 2.1 to 3.4
|
0.4 Z-Score
Interval -0.1 to 0.8
|
SECONDARY outcome
Timeframe: Weeks 0, 24, and 48Population: Participants with MUAC data available
Change in mid-upper arm circumference (MUAC) from entry
Outcome measures
| Measure |
Severe Malnutrition Cohort
n=23 Participants
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition Cohort
n=24 Participants
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Change in Mid-upper Arm Circumference
Week 24
|
2.6 centimeters
Interval 2.0 to 3.3
|
1.2 centimeters
Interval 0.8 to 1.6
|
|
Change in Mid-upper Arm Circumference
Week 48
|
3.5 centimeters
Interval 2.8 to 4.2
|
1.6 centimeters
Interval 1.2 to 2.0
|
Adverse Events
Severe Malnutrition
Serious events: 9 serious events
Other events: 25 other events
Deaths: 3 deaths
Normal Nutrition/Mild Malnutrition
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Severe Malnutrition
n=25 participants at risk
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition
n=27 participants at risk
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Pulmonary tuberculosis
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Haemoglobin decreased
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Neutrophil count decreased
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Malnutrition
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
Other adverse events
| Measure |
Severe Malnutrition
n=25 participants at risk
Severe Acute Malnutrition at Entry ZDV+3TC+LPV/r
|
Normal Nutrition/Mild Malnutrition
n=27 participants at risk
Normal Nutrition or Mild Malnutrition at Entry ZDV+3TC+LPV/r
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
14.8%
4/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Ear and labyrinth disorders
Otorrhoea
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Eye disorders
Eye discharge
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Eye disorders
Ocular hyperaemia
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.0%
11/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
22.2%
6/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Oral disorder
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Gastrointestinal disorders
Vomiting
|
32.0%
8/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
General disorders
Pyrexia
|
44.0%
11/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
37.0%
10/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Conjunctivitis
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Gastroenteritis
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Impetigo
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Oral candidiasis
|
24.0%
6/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Otitis media acute
|
24.0%
6/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Plasmodium falciparum infection
|
24.0%
6/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Pneumonia bacterial
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
18.5%
5/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Tinea faciei
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Aspartate aminotransferase increased
|
24.0%
6/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood albumin decreased
|
64.0%
16/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
37.0%
10/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood bicarbonate decreased
|
92.0%
23/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
74.1%
20/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood cholesterol increased
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood glucose decreased
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
14.8%
4/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood glucose increased
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood potassium decreased
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood potassium increased
|
40.0%
10/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
29.6%
8/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood sodium decreased
|
48.0%
12/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
55.6%
15/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Blood triglycerides increased
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
14.8%
4/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Haemoglobin decreased
|
88.0%
22/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
77.8%
21/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Neutrophil count decreased
|
28.0%
7/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
63.0%
17/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Platelet count decreased
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Investigations
Weight decreased
|
28.0%
7/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Malnutrition
|
84.0%
21/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
22.2%
6/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
20.0%
5/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Metabolism and nutrition disorders
Underweight
|
24.0%
6/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Psychiatric disorders
Selective eating disorder
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
68.0%
17/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
51.9%
14/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
3.7%
1/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
32.0%
8/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
25.9%
7/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
12.0%
3/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Papule
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
4.0%
1/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
7.4%
2/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
11.1%
3/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
|
Vascular disorders
Pallor
|
8.0%
2/25 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
0.00%
0/27 • From study entry to study completion at Week 48 or premature study discontinuation
Serious Adverse Event (SAE) Reporting Category \[v2.0 of the DAIDS expedited adverse event Manual\] was used. Study agents for which relationship assessments were required: ZDV, 3TC, LPV/r and abacavir. Other events reported in an expedited fashion included malignancies, seizures and Grade 3/4 hepatotoxicities, and Grade 3/4 related toxicities where a relationship to study drug could not be ruled out. Events were summarized if onset was on or after entry.
|
Additional Information
IMPAACT Clinicaltrials.gov Coordinator
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
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