Trial Outcomes & Findings for Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis (NCT NCT01427738)
NCT ID: NCT01427738
Last Updated: 2015-02-16
Results Overview
The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
After 14 days of treatment
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
Arm A: Topical GV Solution
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
111
|
|
Overall Study
COMPLETED
|
91
|
90
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
| Measure |
Arm A: Topical GV Solution
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Overall Study
Death
|
12
|
9
|
|
Overall Study
Severe debilitation, unable to continue
|
0
|
1
|
|
Overall Study
Subject unable to get to clinic
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Subject not willing to adhere to reqs
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
Baseline Characteristics
Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis
Baseline characteristics by cohort
| Measure |
Arm A: Topical GV Solution
n=110 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=111 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
10-19 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
17 participants
n=5 Participants
|
30 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
54 participants
n=5 Participants
|
52 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Age, Customized
Over 60 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
97 participants
n=5 Participants
|
106 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
13 participants
n=5 Participants
|
5 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Antiretroviral Therapy Usage
On ART
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Antiretroviral Therapy Usage
Not on ART
|
83 participants
n=5 Participants
|
83 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
CD4 Count
0-200 cells/microliter
|
87 participants
n=5 Participants
|
88 participants
n=7 Participants
|
175 participants
n=5 Participants
|
|
CD4 Count
> 200 cells/microliter
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
HIV RNA Viral Load
|
4.89 log10(copies/ml)
STANDARD_DEVIATION 1.31 • n=5 Participants
|
5.03 log10(copies/ml)
STANDARD_DEVIATION 1.21 • n=7 Participants
|
4.96 log10(copies/ml)
STANDARD_DEVIATION 1.26 • n=5 Participants
|
PRIMARY outcome
Timeframe: After 14 days of treatmentPopulation: Out of 221 subjects,17 had oral exams at entry but not week 2: 11 premature discontinuation, 2 missed visits, and 4 without specific reasons. 204 subjects received oral exams at both entry and week 2. 2 more participants were excluded from the final analysis because they had no pseudomem candi at entry, which led to a total of 202 subjects.
The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=100 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=102 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Number of Participants With Clinical Efficacy
|
76 participants
|
73 participants
|
SECONDARY outcome
Timeframe: after 14 days of treatmentPopulation: At entry, a total of 217 observations (106 in GV arm; 111 in nystatin arm) were available to evaluate the symptoms (pain and discomfort) associated with OC. At the end of treatment, a total of 204 observations were available to evaluate the symptoms associated with OC using extended Mantel-Haenszel test between GV and nystatin arms.
Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=106 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=111 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Number of Participant With Symptom
Pain at entry
|
106 participants
|
111 participants
|
|
Number of Participant With Symptom
Pain at end of treatment
|
102 participants
|
102 participants
|
|
Number of Participant With Symptom
Discomfort at entry
|
106 participants
|
111 participants
|
|
Number of Participant With Symptom
Discomfort at end of treatment
|
102 participants
|
102 participants
|
SECONDARY outcome
Timeframe: At weeks 0, 2, 6Population: At entry, 210 observations were available (182 had positive culture result for Candida specimen, and 175 of those had colony count performed) to evaluate quantitative yeast colony counts. N= 78 (GV), 70 (Nystatin) at end of treatment; N= 51 (GV), 35 (Nystatin) at week 6;
If quantitative yeast culture yielding \< 20 CFU/mL of Candida spp., then we call this mycological success
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=88 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=87 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Quantitative Yeast Colony Counts
At entry, week 0
|
7.2497 CFU/mL
Standard Deviation 2.2382
|
7.0037 CFU/mL
Standard Deviation 2.0584
|
|
Quantitative Yeast Colony Counts
At end of treatment (week 2)
|
6.9374 CFU/mL
Standard Deviation 2.1438
|
5.8888 CFU/mL
Standard Deviation 2.3970
|
|
Quantitative Yeast Colony Counts
At week 6
|
6.7388 CFU/mL
Standard Deviation 2.3469
|
6.5929 CFU/mL
Standard Deviation 2.3668
|
SECONDARY outcome
Timeframe: After 14 days of treatmentPopulation: The analysis for tolerance was based on 208 observations.
The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=103 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=105 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Tolerance
No side effects, no changes in treatment
|
100 participants
|
98 participants
|
|
Tolerance
Some side effects, no changes in treatment
|
3 participants
|
6 participants
|
|
Tolerance
Some side effects, treatment interruption
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: After 14 days of treatmentPopulation: The analysis for adherence was based on 209 observations.
Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28\*0.15=4 doses; and for the nystatin arm is 56\*0.15=8 doses.
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=104 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=105 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Number of Participants Who Were Adherent.
Adherent
|
95 participants
|
95 participants
|
|
Number of Participants Who Were Adherent.
Non-adherent
|
9 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Weeks 0, 6Population: N=110 (GV), 110 (Nystatin) wk 0 N= 96 (GV), 95 (Nystatin) wk 6
Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=110 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=110 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Self-Assessment of General Health
Week 0: Excellent
|
1 participants
|
4 participants
|
|
Self-Assessment of General Health
Week 0: Very Good
|
13 participants
|
11 participants
|
|
Self-Assessment of General Health
Week 0: Good
|
52 participants
|
56 participants
|
|
Self-Assessment of General Health
Week 0: Fair
|
39 participants
|
30 participants
|
|
Self-Assessment of General Health
Week 0: Poor
|
5 participants
|
9 participants
|
|
Self-Assessment of General Health
Week 6: Excellent
|
5 participants
|
7 participants
|
|
Self-Assessment of General Health
Week 6: Very Good
|
29 participants
|
25 participants
|
|
Self-Assessment of General Health
Week 6: Good
|
42 participants
|
42 participants
|
|
Self-Assessment of General Health
Week 6: Fair
|
18 participants
|
18 participants
|
|
Self-Assessment of General Health
Week 6: Poor
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: After 14 days of treatmentPopulation: The analysis for acceptability of treatment was based on 209 subjects.
Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.
Outcome measures
| Measure |
Arm A: Topical GV Solution
n=104 Participants
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Arm B: Nystatin Oral Suspension
n=105 Participants
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Number of Participants Who Found GV and Nystatin Acceptable.
|
100 participants
|
98 participants
|
Adverse Events
Gentian Violet
Serious events: 18 serious events
Other events: 103 other events
Deaths: 0 deaths
Nystatin
Serious events: 17 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gentian Violet
n=110 participants at risk
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Nystatin
n=111 participants at risk
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
2/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
1.8%
2/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
General disorders
Death
|
1.8%
2/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Encephalitis viral
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Gastroenteritis
|
1.8%
2/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
HIV infection WHO clinical stage IV
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Malaria
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Meningitis
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
1.8%
2/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Meningitis cryptococcal
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Oesophageal candidiasis
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Pneumonia
|
1.8%
2/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Pulmonary tuberculosis
|
2.7%
3/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
1.8%
2/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Sepsis
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Septic shock
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Liver function test abnormal
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Renal and urinary disorders
Renal failure acute
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Vascular disorders
Hypotension
|
0.00%
0/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.90%
1/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
Other adverse events
| Measure |
Gentian Violet
n=110 participants at risk
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days
Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days.
|
Nystatin
n=111 participants at risk
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days
Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Cheilitis
|
8.2%
9/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
4.5%
5/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
6/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
5.4%
6/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Leukoplakia oral
|
5.5%
6/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
3.6%
4/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Odynophagia
|
5.5%
6/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
2.7%
3/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Oral disorder
|
10.0%
11/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
12.6%
14/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
4.5%
5/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
7.2%
8/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
7/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
5.4%
6/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
General disorders
Chest pain
|
7.3%
8/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.0%
10/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
General disorders
Pyrexia
|
4.5%
5/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
8.1%
9/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Oral candidiasis
|
28.2%
31/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
23.4%
26/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Oral hairy leukoplakia
|
5.5%
6/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.9%
11/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Pneumonia bacterial
|
4.5%
5/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
7.2%
8/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Infections and infestations
Pulmonary tuberculosis
|
8.2%
9/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
5.4%
6/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Alanine aminotransferase increased
|
10.9%
12/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
5.4%
6/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Aspartate aminotransferase increased
|
28.2%
31/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
23.4%
26/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood albumin decreased
|
52.7%
58/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
47.7%
53/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood alkaline phosphatase increased
|
16.4%
18/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.9%
11/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood bicarbonate decreased
|
19.1%
21/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
18.0%
20/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood calcium decreased
|
39.1%
43/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
45.0%
50/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood creatinine increased
|
6.4%
7/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
4.5%
5/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood glucose decreased
|
0.91%
1/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
5.4%
6/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood glucose increased
|
6.4%
7/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
8.1%
9/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood magnesium decreased
|
10.0%
11/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.0%
10/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood phosphorus decreased
|
9.1%
10/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.0%
10/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood potassium decreased
|
8.2%
9/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
9.9%
11/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood sodium decreased
|
47.3%
52/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
33.3%
37/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Blood uric acid increased
|
9.1%
10/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
18.0%
20/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Haemoglobin decreased
|
30.0%
33/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
29.7%
33/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
Neutrophil count decreased
|
20.0%
22/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
26.1%
29/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Investigations
White blood cell count decreased
|
15.5%
17/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
20.7%
23/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
9/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
8.1%
9/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
6.4%
7/110 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
0.00%
0/111 • From entry (week 0) to end of study.
The protocol requested reporting of grade 3 or higher of adverse events and any adverse event that led to a change in study treatment, regardless of grade. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009), was used for grading
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place