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

Human Immunodeficiency Virus Clinical Trial

— MSPB_TB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065905
• Other study ID #: MSPB_TB
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Aids/Hiv Problem
• Coinfection
• Communicable Diseases
• HIV Coinfection
• HIV Infections
• Human Immunodeficiency Virus
• Infections
• Lentivirus Infections
• RNA Virus Infections
• Tuberculosis
• Tuberculosis, Pulmonary

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