Trial Outcomes & Findings for Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis (NCT NCT05065905)
NCT ID: NCT05065905
Last Updated: 2024-01-25
Results Overview
Precentage of participants with negative sputum culture
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Week 4
Results posted on
2024-01-25
Participant Flow
Participant milestones
| Measure |
Interferon
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Interferon Daily
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Control
All participants receive only basic antimicrobial treatment
Interventions:
Drug: Antituberculosis complex therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
20
|
|
Overall Study
COMPLETED
|
30
|
28
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
Baseline characteristics by cohort
| Measure |
Interferon
n=30 Participants
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Interferon Daily
n=28 Participants
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Control
n=20 Participants
All participants receive only basic antimicrobial treatment
Interventions:
Drug: Antituberculosis complex therapy
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
under 18 y.o.
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18-50 y.o.
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Age, Customized
over 50 y.o.
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
20 participants
n=5 Participants
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Precentage of participants with negative sputum culture
Outcome measures
| Measure |
Interferon
n=30 Participants
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Interferon Daily
n=28 Participants
All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day
Interventions:
Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy
Interferon-Gamma: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
|
Control
n=20 Participants
All participants receive only basic antimicrobial treatment
Interventions:
Drug: Antituberculosis complex therapy
|
|---|---|---|---|
|
Sputum Culture
|
15 Participants
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Screening, Week 8Level of hemoglobin (g/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Week 4Number of leukocytes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Week 4CD3 cells level in absolute numbers and percents
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Week 4CD4 cells level in absolute numbers and percents
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Week 4CD8 cells level in absolute numbers and percents
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Week 4Immunoregulatory index value
Outcome measures
Outcome data not reported
Adverse Events
Interferon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interferon Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. med. Sc., Prof. Tamara Sologub
Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health, Saint-Petersburg, Russia, 195067
Phone: +78125439609
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place