Clinical Trials Logo
  1. Home
  2. HIV Coinfection
  3. NCT05065905

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

Human Immunodeficiency Virus Clinical Trial

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 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 NCT02812329 - Intervention to Encourage HIV Testing and Counseling Among Adolescents Phase 1
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 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 NCT01460433 - Problems With Immune Recovery in the Gut Tissue N/A
Completed NCT01490346 - Tissue Drug Levels of HIV Medications 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