Human Immunodeficiency Virus Clinical Trial
— MSPB_TBOfficial 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
Verified date | September 2021 |
Source | SPP Pharmaclon Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
SPP Pharmaclon Ltd. | North-Western State Medical University named after I.I.Mechnikov |
Russian Federation,
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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