Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis : A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.The treatment regimen in this study will also include a basic antituberculosis therapy.The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 25. Jan. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: October 4, 2021, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2024, Last updated: January 31, 2024 |
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| Study ID: |
NCT05065905 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG007921241 |
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| 245 | 1 | 0 | |a Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis |b A I//II Phase Study of the Efficacy and Safety of Interferon-Gamma by Subcutaneous Injection in the Complex Treatment of Patients Infected With HIV and Tuberculosis |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: October 4, 2021, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2024, Last updated: January 31, 2024 | ||
| 520 | |a Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.The treatment regimen in this study will also include a basic antituberculosis therapy.The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group. | ||
| 650 | 2 | |a Infections | |
| 650 | 2 | |a Communicable Diseases | |
| 650 | 2 | |a Tuberculosis | |
| 650 | 2 | |a Acquired Immunodeficiency Syndrome | |
| 650 | 2 | |a HIV Infections | |
| 650 | 2 | |a Coinfection | |
| 650 | 2 | |a Tuberculosis, Pulmonary | |
| 650 | 2 | |a RNA Virus Infections | |
| 650 | 2 | |a Lentivirus Infections | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 1, Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 25. Jan. |
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