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

Phase 1

Completed

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

• Registration Number: NCT05065905
• Lead Sponsor: SPP Pharmaclon Ltd.

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.

Study Timeline

• Study Start: 2006-01-19
• Primary Completion: 2006-03-29
• Study Completion: 2006-04-06
• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Results First Submitted: 2023-04-25
• Results First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Results First Posted: 2024-01-25
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon	Interferon-Gamma	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
Interferon daily	Interferon-Gamma	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

Primary Outcome Measures

Name	Time	Method
Sputum Culture	Week 4	Precentage of participants with negative sputum culture

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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; 🇷🇺 Saint Petersburg, Saint-Petersburg, Russian Federation