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

NCT ID: NCT05065905

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-19
• Study Completion Date: 2006-04-06

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Interferon-Gamma

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Interferon-Gamma

Intervention Type: DRUG

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

Control

All participants receive only basic antimicrobial treatment

Interventions:

Drug: Antituberculosis complex therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interferon-Gamma

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

Intervention Type: DRUG

Other Intervention Names

Ingaron; Interferon gamma human recombinant

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North-Western State Medical University named after I.I.Mechnikov

OTHER

Sponsor Role: collaborator

SPP Pharmaclon Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Shmelev, Doctor

Role: STUDY_DIRECTOR

SPP Pharmaclon Ltd.

Locations

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

Saint Petersburg, Sankt-Peterburg, Russia

City Tuberculosis Hospital #2 of Saint-Petersburg

Saint Petersburg, Sankt-Peterburg, Russia

Countries

Russia

Other Identifiers

MSPB_TB

Identifier Type: -

Identifier Source: org_study_id