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 |
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 |
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 |
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 |