Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03069417 - Support for Perinatal Adherence and Depression N/A
Terminated NCT03516318 - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria N/A
Recruiting 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 NCT04191967 - Thermocoagulation for Treatment of Precancerous Cervical Lesions N/A
Not yet recruiting NCT04393935 - Pharmacy-based Pre-exposure Prophylaxis N/A
Completed NCT02812329 - Intervention to Encourage HIV Testing and Counseling Among Adolescents Phase 1
Completed NCT02516930 - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China N/A
Completed NCT02651376 - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients Phase 1/Phase 2
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 NCT01076179 - Kaletra in Combination With Antiretroviral Agents 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 NCT00317460 - Buprenorphine and Integrated HIV Care Phase 4
Completed NCT03254277 - 3BNC117-LS First-in-Human Phase 1 Study Phase 1
Terminated NCT01692236 - Brain Imaging for HIV-Associated Thinking and Mood Disorders
Recruiting NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4