Clinical trial NCT05065905: Study of Interferon-Gamma in the Complex Treatment of Patients Infected With HIV and Tuberculosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Coinfection
Aids/Hiv Problem
Tuberculosis, Pulmonary
Human Immunodeficiency Virus
Lentivirus Infections
RNA Virus Infections
Keywords: interferon gamma, IFN-g, HIV infection, tuberculosis
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
Collaborators: name: North-Western State Medical University named after I.I.Mechnikov
First posted: 2021-10-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sputum Culture
timeFrame: Week 4
Secondary outcomes:
measure: Average Hemoglobin Level
timeFrame: Screening, Week 8
measure: Leucocytes Level
timeFrame: Screening, Week 4
measure: CD3
timeFrame: Screening, Week 4
measure: CD4
timeFrame: Screening, Week 4
measure: CD8
timeFrame: Screening, Week 4
measure: CD4/CD8
timeFrame: Screening, Week 4
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: City Tuberculosis Hospital #2 of Saint-Petersburg
state: Saint-Petersburg
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Vladimir Shmelev, Doctor
role: STUDY_DIRECTOR
References: