Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Coinfection, Aids/Hiv Problem, Tuberculosis, Pulmonary, Human Immunodeficiency Virus, Lentivirus Infections, RNA Virus Infections

Intervention / Treatment
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* Drug: Interferon-Gamma


Participation Criteria
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Eligibility Criteria
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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 Age 18-50 years Pulmonary tuberculosis HIV/AIDS Indication for in-patient standard antituberculosis treatment Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon<br>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<br>* received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein<br>* Other names: Interferon gamma human recombinant;|
| Experimental: Interferon daily<br>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<br>* received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein<br>* Other names: Interferon gamma human recombinant;|
| No Intervention: Control<br>All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum culture | Precentage of participants with negative sputum culture | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average hemoglobin level | Level of hemoglobin (g/L) | Screening, Week 8 | 
| Leucocytes level | Number of leukocytes | Screening, Week 4 | 
| CD3 | CD3 cells level in absolute numbers and percents | Screening, Week 4 | 
| CD4 | CD4 cells level in absolute numbers and percents | Screening, Week 4 | 
| CD8 | CD8 cells level in absolute numbers and percents | Screening, Week 4 | 
| CD4/CD8 | Immunoregulatory index value | Screening, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interferon gamma, IFN-g, HIV infection, tuberculosis