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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05065905
Other study ID # MSPB_TB
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 19, 2006
Est. completion date April 6, 2006

Study information

Verified date September 2021
Source SPP Pharmaclon Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date April 6, 2006
Est. primary completion date March 29, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Russian Federation City Tuberculosis Hospital #2 of Saint-Petersburg Saint Petersburg Saint-Petersburg
Russian Federation Saint-Petersburg State Medical Academy n.a. I.I.Mechnikov of Ministry of Health Saint Petersburg Saint-Petersburg

Sponsors (2)

Lead Sponsor Collaborator
SPP Pharmaclon Ltd. North-Western State Medical University named after I.I.Mechnikov

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sputum Culture Precentage of participants with negative sputum culture Week 4
Secondary Average Hemoglobin Level Level of hemoglobin (g/L) Screening, Week 8
Secondary Leucocytes Level Number of leukocytes Screening, Week 4
Secondary CD3 CD3 cells level in absolute numbers and percents Screening, Week 4
Secondary CD4 CD4 cells level in absolute numbers and percents Screening, Week 4
Secondary CD8 CD8 cells level in absolute numbers and percents Screening, Week 4
Secondary CD4/CD8 Immunoregulatory index value Screening, Week 4
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