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

NCT05065905 | Completed Phase 1 Results

• 1 other identifier: MSPB_TB
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

interferon gamma, IFN-g, HIV infection, tuberculosis

Outcome Measures

Primary Outcomes (1)

• Sputum Culture

  Precentage of participants with negative sputum culture

  Week 4

Secondary Outcomes (6)

• Average Hemoglobin Level

  Screening, Week 8

• Leucocytes Level

  Screening, Week 4

• CD3

  Screening, Week 4

• CD4

  Screening, Week 4

• CD8

  Screening, Week 4

Study Arms (3)

Interferon

EXPERIMENTAL

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

Interferon daily

EXPERIMENTAL

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

Control

NO INTERVENTION

All participants receive only basic antimicrobial treatment Interventions: Drug: Antituberculosis complex therapy

Interventions

Interferon-Gamma DRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Also known as: Ingaron, Interferon gamma human recombinant

Interferon; Interferon daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead
• North-Western State Medical University named after I.I.Mechnikov: collaborator

Study Sites (2)

Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health

Saint Petersburg, Sankt-Peterburg, 195067, Russia

Location

City Tuberculosis Hospital #2 of Saint-Petersburg

Saint Petersburg, Sankt-Peterburg, Russia

Location

MeSH Terms

Conditions

HIV Infections; Tuberculosis, Pulmonary; Acquired Immunodeficiency Syndrome; Lentivirus Infections; RNA Virus Infections; Tuberculosis

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Retroviridae Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. med. Sc., Prof. Tamara Sologub
• Organization: Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health, Saint-Petersburg, Russia, 195067

mechnik@mail.ru

+78125439609

Study Officials

• Vladimir Shmelev, Doctor

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 4, 2021
• Study Start: January 19, 2006
• Primary Completion: March 29, 2006
• Study Completion: April 6, 2006
• Last Updated: January 25, 2024
• Results First Posted: January 25, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)