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The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.
Monitoring of a patient in a hospital is carried out daily by the attending physician during the entire period of the patient's stay at the research center. When prescribing the drug Ingaron, the researcher must follow the instructions for use of the drug. As part of 4 control observations to assess effectiveness and safety:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Ingaron 500,000 IU intramuscularly 1 time per day daily or every other day for 2 months (60 days) - a total of 30 or 60 injections + basic anti-tuberculosis therapy |
| |
| No Intervention | only basic anti-tuberculosis therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-Gamma | Drug | received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of abacillated patients | Proportion of abacillated patients according to fluorescence microscopy | 1 month |
| Proportion of abacillated patients | Proportion of abacillated patients according to culture data | 1 month |
| Proportion of abacillated patients | Proportion of abacillated patients according to fluorescence microscopy | 2 month |
| Proportion of abacillated patients | Proportion of abacillated patients according to culture data | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who died | deaths associated with HIV infection and/or tuberculosis | 5 month |
| Proportion of patients who required a change in therapy | Proportion of patients who required a change in therapy due to ineffectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with tuberculosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia A Isakova, Master | Contact | 8 107 905 535-33-11 | isakova@pharmaclon.ru | |
| Polina I Pekhtereva, Master | Contact | 8 107 909 675-96-43 | pekhtereva@pharmaclon.ru |
| Name | Affiliation | Role |
|---|---|---|
| Anatoly I Saulin, Master | SPP Pharmaclon Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astrakhan Oblast Tuberculosis Clinic | Recruiting | Astrakhan | Astrakhan Oblast | 414004 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39871554 | Derived | Izosimova VE, Barmina NA, Zharikova MP, Alekseyev OY, Ryzhkova OA, Sayfulin MH, Popova NA, Andreyev MA, Gagarina SG, Rysdauletova RM, Kamaeva NG, Samoylova AG, Romanova MI. A Clinical Multicenter Trial of Recombinant Human Interferon Gamma in Tuberculosis (GAM2022): Experience with the Use of Human Recombinant Interferon Gamma in TB Practice. Infect Disord Drug Targets. 2025;25(6):e18715265329137. doi: 10.2174/0118715265329137250102103507. |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| 5 month |
| Proportion of patients with adverse reactions | Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance | 5 month |
| Changes in the level of CD4 lymphocytes and HIV viral load in the blood | Changes in the level of CD4 lymphocytes and HIV viral load in the blood (Proportion of patients with a CD4 level less than 350 cells/ml) | 5 month |
| Tuberculosis Clinic of the Republic of Bashkortostan | Completed | Ufa | Bashkortostan Republic | 450080 | Russia |
| Tuberculosis Clinic of the Chuvash Republic | Recruiting | Cheboksary | Chuvashskaya Respublika | 428015 | Russia |
|
| Leningrad Oblast Tuberculosis Clinic | Completed | Slantsy | Leningradskaya Oblast' | 188560 | Russia |
| Leningrad Oblast Tuberculosis Hospital in Tikhvin | Completed | Tikhvin | Leningradskaya Oblast' | 187550 | Russia |
| Clinical Phthisiopulmonological Medical Center | Recruiting | Perm | Perm Krai | 614990 | Russia |
|
| Ryazan Oblast Tuberculosis Clinic | Completed | Ryazan | Ryazan Oblast | 390046 | Russia |
| Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases | Completed | Yekaterinburg | Sverdlovsk Oblast | 620142 | Russia |
| Republican Tuberculosis Clinic | Recruiting | Kazan' | Tatarstan Republic | 420075 | Russia |
|
| Volgograd Oblast Tuberculosis Clinic | Recruiting | Volgograd | Volgograd Oblast | 400005 | Russia |
|
| N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary | Completed | Voronezh | Voronezh Oblast | 394070 | Russia |
| Yaroslavl regional tuberculosis clinic | Completed | Yaroslavl | Yaroslavl Oblast | 152284 | Russia |
| City tuberculosis clinic | Not yet recruiting | Saint Petersburg | 196142 | Russia |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |