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

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

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.

Study Overview

• Status: Completed
• Conditions: RNA Virus Infections; Lentivirus Infections; Tuberculosis, Pulmonary; Human Immunodeficiency Virus; HIV Coinfection; Aids/Hiv Problem
• Intervention / Treatment: Drug: Interferon-Gamma

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg
    • Saint Petersburg, Saint-Petersburg, Russian Federation, 195067
      • Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health
    • Saint Petersburg, Saint-Petersburg, Russian Federation
      • City Tuberculosis Hospital #2 of Saint-Petersburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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: Ingaron; Interferon gamma human recombinant
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: Ingaron; Interferon gamma human recombinant
No Intervention: Control; All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy

What is the study measuring?

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
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
Average Hemoglobin Level	Level of hemoglobin (g/L)	Screening, Week 8
Leucocytes Level	Number of leukocytes	Screening, Week 4

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.
• Collaborators: North-Western State Medical University named after I.I.Mechnikov
• Investigators: Study Director: Vladimir Shmelev, Doctor, SPP Pharmaclon Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2006
• Primary Completion (Actual): March 29, 2006
• Study Completion (Actual): April 6, 2006

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: interferon gamma, IFN-g, HIV infection, tuberculosis
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Infections; Communicable Diseases; Tuberculosis; Acquired Immunodeficiency Syndrome; Tuberculosis, Pulmonary; Coinfection; RNA Virus Infections; Lentivirus Infections; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: MSPB_TB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No