Trial Outcomes & Findings for A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines (NCT NCT01172535)
NCT ID: NCT01172535
Last Updated: 2021-11-05
Results Overview
Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
97 participants
Primary outcome timeframe
Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose
Results posted on
2021-11-05
Participant Flow
There were 97 participants enrolled from 19 clinical sites in four countries. There were 57 participants on the liquid formulation and 40 on tablet. Accrual took place from May 20, 2011 through June 19, 2013.
HIV-infected infants and children ≥3 to \<25 kg had to be LPV/r-treatment naïve. Children ≥10 kg had to demonstrate ability and willingness to swallow tablets. Participants were stratified by weight and drug formulation (liquid vs. tablet).
Participant milestones
| Measure |
Lopinavir/Ritonavir
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Lopinavir/Ritonavir
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Ineligible at study entry
|
1
|
|
Overall Study
Unwilling to adhere to study requirement
|
1
|
Baseline Characteristics
A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
Baseline characteristics by cohort
| Measure |
Lopinavir/Ritonavir
n=97 Participants
Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
|---|---|
|
Age, Continuous
|
2.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
32 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
37 participants
n=5 Participants
|
|
HIV RNA (copies/mL) at study entry
|
5.2 log copies/mL
n=5 Participants
|
|
CD4% at study entry
|
24.2 percentage of total lymphocytes
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dosePopulation: Participants having complete pharmacokinetics data at week 4
Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=81 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)
|
196 mcg*hr/mL
Interval 177.0 to 217.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dosePopulation: Participants having complete pharmacokinetics data at week 4
Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=81 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Maximum Concentration of Lopinavir/Ritonavir (Cmax)
|
11.25 mcg/mL
Interval 10.24 to 12.35
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dosePopulation: Participants having complete pharmacokinetics data at week 4
Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=81 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Minimum Concentration of Lopinavir/Ritonavir (Cmin)
|
2.47 mcg/mL
Interval 1.52 to 4.02
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dosePopulation: Participants having complete pharmacokinetics data at week 4
Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=81 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Clearance of Lopinavir/Ritonavir (CL/F)
|
0.15 L/h/kg
Interval 0.13 to 0.17
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dosePopulation: Participants with complete pharmacokinetics data at week 4
Proportion of participants with an AUC less that 10% of adults (AUC0-24 \<104 mcg\*hr/mL)
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=81 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Proportion of Participants With an AUC of Less Than 10% of Adults
|
0.15 proportion of participants
Interval 0.09 to 0.23
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at study visits through end of study (weeks 2, 4, 12, 24)Population: All participants
Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=97 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events of Grade 3 or 4
|
32 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at study completion (week 24)Population: All participants
Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=97 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Proportion of Participants Tolerating LPV/r
|
0.93 proportion of participants
Interval 0.86 to 0.97
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at week 4, week 12, and study completion (week 24)Population: Participants bringing medication to be measured at the study visit
Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=62 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
n=59 Participants
Participants bringing medication to be measured at study week 12
|
Week 24
n=59 Participants
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Adherence
|
1.00 Proportion of expected doses taken
Interval 0.97 to 1.1
|
0.99 Proportion of expected doses taken
Interval 0.88 to 1.01
|
1.00 Proportion of expected doses taken
Interval 0.91 to 1.01
|
SECONDARY outcome
Timeframe: Measured at entry and study completion (week 24)Population: Participants with data from both study entry and the week 24 study visit
Having HIV viral load \<400 copies/mL at the week 24 visit
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=79 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Treatment Efficacy (HIV Viral Load)
|
0.72 proportion of participants
Interval 0.61 to 0.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at entry and study completion (week 24)Population: Participants with data from both study entry and the week 24 study visit
Having CD4%≥25 at the week 24 visit.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=83 Participants
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
Week 12
Participants bringing medication to be measured at study week 12
|
Week 24
Participants bringing medication to be measured at study week 24
|
|---|---|---|---|
|
Treatment Efficacy (CD4%)
|
0.71 proportion of participants
Interval 0.6 to 0.81
|
—
|
—
|
Adverse Events
LPV/r
Serious events: 20 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LPV/r
n=97 participants at risk
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Cardiac disorders
Cardiomyopathy
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
General disorders
Drowning
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Gastroenteritis
|
2.1%
2/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Immune reconstitution inflammatory syndrome associated tuberculosis
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Influenza
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Measles
|
2.1%
2/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Pneumonia
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Pneumonia bacterial
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Amylase increased
|
3.1%
3/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
Other adverse events
| Measure |
LPV/r
n=97 participants at risk
Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
|
|---|---|
|
Infections and infestations
Pneumonia bacterial
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Alanine aminotransferase abnormal
|
5.2%
5/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
18/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Amylase abnormal
|
40.2%
39/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Aspartate aminotransferase increased
|
18.6%
18/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood bicarbonate decreased
|
55.7%
54/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood calcium decreased
|
11.3%
11/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood calcium increased
|
25.8%
25/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood cholesterol increased
|
19.6%
19/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.2%
8/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Eye disorders
Conjunctival pallor
|
5.2%
5/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Eye disorders
Eye discharge
|
8.2%
8/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.0%
33/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Gastrointestinal disorders
Vomiting
|
30.9%
30/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
General disorders
Pyrexia
|
43.3%
42/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Hepatobiliary disorders
Hepatomegaly
|
9.3%
9/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
5.2%
5/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Bronchitis
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Gastroenteritis
|
13.4%
13/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Impetigo
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Infections and infestations
Pharyngitis
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood glucose decreased
|
19.6%
19/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood glucose increased
|
9.3%
9/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood magnesium decreased
|
10.3%
10/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood phosphorus decreased
|
8.2%
8/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood potassium decreased
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood potassium increased
|
14.4%
14/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Blood sodium decreased
|
59.8%
58/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Breath sounds abnormal
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Haemoglobin decreased
|
41.2%
40/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Neutrophil count decreased
|
25.8%
25/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Investigations
Platelet count decreased
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
5/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
49.5%
48/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
8/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
10/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
5/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.4%
12/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
44.3%
43/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
11.3%
11/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.2%
7/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Papule
|
13.4%
13/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
18/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
6/97 • From entry until off-study (week 24)
Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included Aes resulting in death, significant disabilities, requiring hospitalization, and ≥grade 3 Aes defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric Aes", V1.0, 12/2004.
|
Additional Information
Melissa Allen, Director, IMPAACT Operations Center
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 seven (7) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER