MSPB_TB: Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
Study Details
Study Description
Brief Summary
The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: Interferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Other Names:
|
Experimental: 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 |
Drug: Interferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Other Names:
|
No Intervention: Control All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy |
Outcome Measures
Primary Outcome Measures
- Sputum culture [Week 4]
Precentage of participants with negative sputum culture
Secondary Outcome Measures
- Average hemoglobin level [Screening, Week 8]
Level of hemoglobin (g/L)
- Leucocytes level [Screening, Week 4]
Number of leukocytes
- CD3 [Screening, Week 4]
CD3 cells level in absolute numbers and percents
- CD4 [Screening, Week 4]
CD4 cells level in absolute numbers and percents
- CD8 [Screening, Week 4]
CD8 cells level in absolute numbers and percents
- CD4/CD8 [Screening, Week 4]
Immunoregulatory index value
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must sign the form of informed consent and agree to follow the protocol requirements
-
Women willing to participate in the study must protect against possible pregnancy during all the study long
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Age 18-50 years
-
Pulmonary tuberculosis
-
HIV/AIDS
-
Indication for in-patient standard antituberculosis treatment
Exclusion Criteria:
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Investigational research agents received within 30 days before the screening and participation in other clinical trials
-
Immunosuppressive medications received within 6 months before the screening
-
Current drug abuse for more than 3 years
-
Contraindications to interferons of standard antimicrobial therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health | Saint Petersburg | Saint-Petersburg | Russian Federation | 195067 |
2 | City Tuberculosis Hospital #2 of Saint-Petersburg | Saint Petersburg | Saint-Petersburg | Russian Federation |
Sponsors and Collaborators
- SPP Pharmaclon Ltd.
- North-Western State Medical University named after I.I.Mechnikov
Investigators
- Study Director: Vladimir Shmelev, Doctor, SPP Pharmaclon Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MSPB_TB