Study of Interferon-Gamma in the Complex Treatment of Patients Infected

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05065905
Study type	Interventional
Source	SPP Pharmaclon Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 19, 2006
Completion date	April 6, 2006

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03516318` - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria	N/A
Completed	`NCT04653194` - Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'	Phase 3
Completed	`NCT01792570` - DRV/r + RPV QD: Efficacy and Toxicity Reduction	Phase 3
Active, not recruiting	`NCT04826562` - Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Phase 4
Completed	`NCT04191967` - Thermocoagulation for Treatment of Precancerous Cervical Lesions	N/A
Completed	`NCT02919306` - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults	Phase 1/Phase 2
Completed	`NCT02812329` - Intervention to Encourage HIV Testing and Counseling Among Adolescents	Phase 1
Completed	`NCT02651376` - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients	Phase 1/Phase 2
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Recruiting	`NCT02392884` - HIV Medication Adherence in Underserved Populations	N/A
Completed	`NCT01944371` - Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study	Phase 1/Phase 2
Recruiting	`NCT01778374` - Mater-Bronx Rapid HIV Testing Project.	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT01490346` - Tissue Drug Levels of HIV Medications	N/A
Completed	`NCT01460433` - Problems With Immune Recovery in the Gut Tissue	N/A
Completed	`NCT01076179` - Kaletra in Combination With Antiretroviral Agents	N/A
Completed	`NCT00317460` - Buprenorphine and Integrated HIV Care	Phase 4
Terminated	`NCT04240210` - Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Phase 4
Active, not recruiting	`NCT04704336` - Integration of Hypertension Management Into HIV Care in Nigeria	N/A
Completed	`NCT03254277` - 3BNC117-LS First-in-Human Phase 1 Study	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms