Trial Outcomes & Findings for Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients (NCT NCT04059770)
NCT ID: NCT04059770
Last Updated: 2025-03-14
Results Overview
Maximum daily temperature lower than 37.8 °C
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
day 14
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
Single Dose of L-AmB
single IV dose of 10 mg/kg of L-AmB on day 1;
n=40
|
2 Doses of L-AmB
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
n=39
|
2 Weeks of L-AmB
IV dose of 3 mg/kg of L-AmB for 2 weeks.
n=39
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Baseline characteristics by cohort
| Measure |
Single Dose of L-AmB
n=40 Participants
single IV dose of 10 mg/kg of L-AmB on day 1;
N=40
|
2 Doses of L-AmB
n=39 Participants
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
N=39
|
2 Weeks of L-AmB
n=39 Participants
IV dose of 3 mg/kg of L-AmB for 2 weeks.
N=39
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
39 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
39 participants
n=5 Participants
|
118 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 14Population: Clinical response on day 14 was 84.0% for the single-dose L-AmB arm-(32/38-1 patient was excluded due to concomitant tuberculosis, and another was lost to follow-up), 69.0% (25/36) for the 2-dose L-AmB arm, with 3 patients being excluded from efficacy analysis (1 individual with central nervous system histoplasmosis, 1 patient with concomitant tuberculosis, and another patient lost to follow-up); in the control group, response rate was 74.0% (28/38), with 1 patient being lost to follow-up.
Maximum daily temperature lower than 37.8 °C
Outcome measures
| Measure |
Single Dose of L-AmB
n=38 Participants
single IV dose of 10 mg/kg of L-AmB on day 1;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
2 Doses of L-AmB
n=36 Participants
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
2 Weeks of L-AmB
n=38 Participants
IV dose of 3 mg/kg of L-AmB for 2 weeks.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
|---|---|---|---|
|
Clinical Response
|
32 Participants
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: day 14Population: Overall survival on day 14 were, respectively: 89.0% (34/38) (single-dose L-AmB-with 2 patients being excluded from efficacy analysis); 78.0% (29/37) (2-dose L-AmB arm-2 patients excluded from efficacy analysis); and 89.7% (35/38) (control group-1 patient excluded from efficacy analysis).
Mortality rates attributed to the cause of death that is not directly and only related to histoplasmosis
Outcome measures
| Measure |
Single Dose of L-AmB
n=38 Participants
single IV dose of 10 mg/kg of L-AmB on day 1;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
2 Doses of L-AmB
n=37 Participants
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
2 Weeks of L-AmB
n=38 Participants
IV dose of 3 mg/kg of L-AmB for 2 weeks.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
|---|---|---|---|
|
Overall Mortality
|
4 Participants
|
8 Participants
|
3 Participants
|
Adverse Events
Single Dose of L-AmB
Serious events: 1 serious events
Other events: 34 other events
Deaths: 4 deaths
2 Doses of L-AmB
Serious events: 6 serious events
Other events: 27 other events
Deaths: 8 deaths
2 Weeks of L-AmB
Serious events: 4 serious events
Other events: 34 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Single Dose of L-AmB
n=38 participants at risk
single IV dose of 10 mg/kg of L-AmB on day 1;
|
2 Doses of L-AmB
n=37 participants at risk
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
|
2 Weeks of L-AmB
n=38 participants at risk
IV dose of 3 mg/kg of L-AmB for 2 weeks.
|
|---|---|---|---|
|
Renal and urinary disorders
KDIGO
|
2.6%
1/38 • Number of events 1 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
16.2%
6/37 • Number of events 6 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
10.5%
4/38 • Number of events 4 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
Other adverse events
| Measure |
Single Dose of L-AmB
n=38 participants at risk
single IV dose of 10 mg/kg of L-AmB on day 1;
|
2 Doses of L-AmB
n=37 participants at risk
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
|
2 Weeks of L-AmB
n=38 participants at risk
IV dose of 3 mg/kg of L-AmB for 2 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Infusion related toxicity
|
18.9%
7/37 • Number of events 7 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
13.5%
5/37 • Number of events 5 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
2.6%
1/38 • Number of events 1 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
|
Renal and urinary disorders
Hypokalemia
|
7.9%
3/38 • Number of events 3 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
16.2%
6/37 • Number of events 6 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
31.6%
12/38 • Number of events 12 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
|
Blood and lymphatic system disorders
Hemoglobin drop
|
18.4%
7/38 • Number of events 7 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
10.8%
4/37 • Number of events 4 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
21.1%
8/38 • Number of events 8 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
|
Renal and urinary disorders
Hypomagnesemia
|
44.7%
17/38 • Number of events 17 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
32.4%
12/37 • Number of events 12 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
34.2%
13/38 • Number of events 13 • 14 days
Kidney and liver toxicity - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10573726/pdf/ciad313.pdf
|
Additional Information
Professor Alessandro C. Pasqualotto
Universidade Federal de Ciências da Saúde de Porto Alegre
Phone: 5551999951614
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place