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NCT Number: NCT05065905

Study of Interferon-Gamma 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.

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Key information

Conditions

HIV Coinfection Acquired Immunodeficiency Syndrome Actinomycetales Infections Aids/Hiv Problem Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Mycobacterium Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Tuberculosis, Pulmonary Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

City Tuberculosis Hospital #2 of Saint-Petersburg, Saint Petersburg, Sankt-Peterburg, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interferon-gamma

Drug

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

Other names: Ingaron, Interferon gamma human recombinant

Primary outcomes

  1. Sputum Culture

    Time frame: Week 4

    Precentage of participants with negative sputum culture

Secondary outcomes

  1. Average Hemoglobin Level

    Time frame: Screening, Week 8

    Level of hemoglobin (g/L)

  2. Leucocytes Level

    Time frame: Screening, Week 4

    Number of leukocytes

  3. CD3

    Time frame: Screening, Week 4

    CD3 cells level in absolute numbers and percents

  4. CD4

    Time frame: Screening, Week 4

    CD4 cells level in absolute numbers and percents

  5. CD8

    Time frame: Screening, Week 4

    CD8 cells level in absolute numbers and percents

  6. CD4/CD8

    Time frame: Screening, Week 4

    Immunoregulatory index value

Sponsors and collaborators

Lead sponsor

SPP Pharmaclon Ltd.

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: MSPB_TB

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Oct 4, 2021
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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