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

Sponsor
SPP Pharmaclon Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05065905
Collaborator
North-Western State Medical University named after I.I.Mechnikov (Other)
78
2
3
2.5
39
15.4

Study Details

Study Description

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 Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 19, 2006
Actual Primary Completion Date :
Mar 29, 2006
Actual Study Completion Date :
Apr 6, 2006

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Sputum culture [Week 4]

      Precentage of participants with negative sputum culture

    Secondary Outcome Measures

    1. Average hemoglobin level [Screening, Week 8]

      Level of hemoglobin (g/L)

    2. Leucocytes level [Screening, Week 4]

      Number of leukocytes

    3. CD3 [Screening, Week 4]

      CD3 cells level in absolute numbers and percents

    4. CD4 [Screening, Week 4]

      CD4 cells level in absolute numbers and percents

    5. CD8 [Screening, Week 4]

      CD8 cells level in absolute numbers and percents

    6. CD4/CD8 [Screening, Week 4]

      Immunoregulatory index value

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health Saint Petersburg Saint-Petersburg Russian Federation 195067
    2 City Tuberculosis Hospital #2 of Saint-Petersburg Saint Petersburg Saint-Petersburg Russian Federation

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Vladimir Shmelev, Doctor, SPP Pharmaclon Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SPP Pharmaclon Ltd.
    ClinicalTrials.gov Identifier:
    NCT05065905
    Other Study ID Numbers:
    • MSPB_TB
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by SPP Pharmaclon Ltd.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 4, 2021