Tuberculosis Clinical Trial
Official title:
Phase 2 Placebo-controlled, Randomized Study of Oral Immunomodulator in TB and TB/HIV Patients
Treatment of multidrug-resistant TB (MDR-TB) is 100 times more expensive than treatment of drug-susceptible TB, requiring intensive clinical management for prolonged time (18-24 months) and more toxic treatment course. In prior open label study the investigators have shown that adding V-5 Immunitor (V5), can reduce treatment duration to one month and enhance by 4-5 fold the efficacy of TB drugs. Furthermore, V5 has been shown to reverse or reduce liver damage caused by chemotherapy. The cost of V5 will be very modest. The investigators propose to conduct placebo-controlled clinical trial in patients with treatment refractory TB so that the clinical benefit of V5 is confirmed.
The first-diagnosed Mycobacterium tuberculosis infection (TB) is curable with the first line
of anti-tuberculosis drugs (ATT) in over 90% of cases within 6 months. The treatment of TB,
refractory to conventional ATT, requires the deployment of second line TB drugs. This
represents a significant challenge, particularly in resource-poor countries.
The incidence of TB in Ukraine prior to 1992 was about 40 cases per 100,000 people. Ten
years later, TB cases increased to over 80/100,000, with mortality doubled from 10.2/100,000
to 21.6/100,000. Drug-resistant TB is now common in Ukraine. Isoniazid and rifampicin
resistance, which defines the MDR-TB, has been found in 44% and 32.9% of TB isolates. The
first Ukrainian case of HIV was reported in 1987. Today, Ukraine has the highest HIV rate in
the Eastern Europe, with increasing proportion of dual infection. For example, in 2002 the
prevalence of TB and HIV co-infection was 6.3%, but in 2006 at least 15.5 % of TB patients
had HIV co-infection.
It is clear that alternative and improved treatment options are needed. If such an
intervention is found, the impact on the healthcare and clinical management of
treatment-refractory TB and TB-HIV patients will be tremendous. The significant efforts are
directed at finding new drugs and vaccines against TB. Immune-based interventions are
actively sought as an adjunct therapy to conventional ATT. In earlier study the
investigators have accidentally observed that when patients with chronic hepatitis C and
HIV-TB were given V5 together with TB drugs it resulted in negative sputum conversion in 95%
of patients within one month. This startling finding had prompted this study. The aim of the
present study is to compare the clinical benefit of TB therapy in combination with V5 versus
combination of placebo with ATT in a representative population of patients who are poorly
manageable due to relapsing TB, MDR-TB, or TB-HIV co-infection.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |