Trial Outcomes & Findings for Ultra Curto (Ultra Short) TB Prevention Therapy (NCT NCT04703075)
NCT ID: NCT04703075
Last Updated: 2025-06-19
Results Overview
To compare treatment success (completion of treatment with \>90% adherence) of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
531 participants
Primary outcome timeframe
6 months
Results posted on
2025-06-19
Participant Flow
531 people signed consent to be screened for eligibility. 31 people did not meet the eligibility criteria. The reasons were: Risk for Bad Outcome n=8, Active TB n=5, Withdrew Consent n=3, Pregnant n=1, Neutropenia n=2, AST/ALT \> 3 times ULN n=8, HIV infection n= 1, Drug-Drug Interaction n=2, Past TB-TPT treatment n=1. 500 people were assigned to a treatment group in the study. 249 were Randomized to Arm A:1HP. 251 were randomized to Arm B: 3HP
Participant milestones
| Measure |
Arm A: 1HP
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
251
|
|
Overall Study
COMPLETED
|
223
|
211
|
|
Overall Study
NOT COMPLETED
|
26
|
40
|
Reasons for withdrawal
| Measure |
Arm A: 1HP
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
7
|
|
Overall Study
Lost to Follow-up
|
6
|
12
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Moved
|
0
|
2
|
|
Overall Study
Index INH Resistant
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
18
|
Baseline Characteristics
Ultra Curto (Ultra Short) TB Prevention Therapy
Baseline characteristics by cohort
| Measure |
Arm A: 1HP
n=249 Participants
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
n=251 Participants
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=93 Participants
|
38 years
n=4 Participants
|
39 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
141 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
296 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
249 Participants
n=93 Participants
|
251 Participants
n=4 Participants
|
500 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo compare treatment success (completion of treatment with \>90% adherence) of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Outcome measures
| Measure |
Arm A: 1HP
n=249 Participants
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
n=251 Participants
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Number of Participants Who Complete Treatment With >90% Adherence
|
223 Participants
|
211 Participants
|
PRIMARY outcome
Timeframe: 6 monthsParticipants with targeted adverse event grade 2 or more or discontinuing treatment for any side effect.
Outcome measures
| Measure |
Arm A: 1HP
n=249 Participants
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
n=251 Participants
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects
|
40 Participants
|
26 Participants
|
Adverse Events
Arm A: 1HP
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm B: 3HP
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: 1HP
n=249 participants at risk
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
n=251 participants at risk
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
0.40%
1/249 • Number of events 1 • Up to 6 months
Targeted adverse events
|
0.80%
2/251 • Number of events 2 • Up to 6 months
Targeted adverse events
|
Other adverse events
| Measure |
Arm A: 1HP
n=249 participants at risk
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg
|
Arm B: 3HP
n=251 participants at risk
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
|
|---|---|---|
|
Hepatobiliary disorders
Hepatotoxicity
|
5.2%
13/249 • Number of events 13 • Up to 6 months
Targeted adverse events
|
4.0%
10/251 • Number of events 10 • Up to 6 months
Targeted adverse events
|
Additional Information
Maria Beatriz Kohler, Senior Research Nurse
Johns Hopkins University School of Medicine
Phone: 4104048921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place