Tuberculosis Clinical Trial
Official title:
Phase 2 Placebo-controlled, Randomized Study of Oral Immunomodulator in TB and TB/HIV Patients
Verified date | August 2012 |
Source | Lisichansk Regional Tuberculosis Dispensary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ukraine: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | January 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Subjects who are at least 18 years old and are willing and capable of providing written-informed consent. - Both men and non-pregnant women will be included. - One group of 30 patients will have HIV. - Another group of 30 patients will have drug-resistant TB (MDR or XDR). - Remaining 60 patients will have drug-sensitive TB of which 30 will be assigned to placebo. - TB infection documented prior to Study Entry by either the presence of TB rapid test or sputum smear positive for acid-fast bacilli (AFB). - At least two independent tests are sought to confirm TB diagnosis. - Agreement to participate in the study and to give a sample of blood for HIV testing. Exclusion Criteria: - Subjects who have already taken V5 in prior trial and those without baseline data. - Those who met inclusion criteria can be retrospectively enrolled. - Those who are re-treated and relapsed will be eligible as long as they are on the same drug regimen as the rest of patients. - Pregnant or breast-feeding women are excluded. - Subjects who have taken anti-retroviral drugs or immunomodulatory therapies within 2 months prior to Entry: - systemic corticosteroids - immune globulin (IV gamma globulin, IVIG) - interferons, - interleukins - pentoxifylline (Trental) - thalidomide - filgrastim (G-CSF) - sargramostim (GM-CSF) - dinitrochlorobenzene (DNCB) - thymosin alpha 1 (thymosin alpha) - thymopentin - inosiplex (Isoprinosine) - polyribonucleoside (Ampligen) - ditiocarb sodium (Imuthiol) - any locally available immune modulators - and any other therapeutic or preventive vaccine. - Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry. - Medical conditions that in the opinion of the local investigator, may obscure the proper observation of the safety or activity of the study treatment; including any acute medical condition of unknown etiology or recent surgery prior to Entry. - Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator, would interfere with adherence to the requirements of this study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ukraine | Lisichansk TB Dispensary | Lisichansk | Luhansk |
Lead Sponsor | Collaborator |
---|---|
Lisichansk Regional Tuberculosis Dispensary | Immunitor USA Inc., National Medical University, Ukraine |
Ukraine,
DOI 10.2217/imt.12.59
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | primary endpoint: sputum smear conversion | Sputum smear conversion at monthly intervals timepoint Rates of pulmonary healing by chest X-ray at the end of study | 12 months | No |
Secondary | liver function | To determine the safety of V5+ATT versus ATT+placebo in TB-infected subjects, Standard parameters, e.g., ALT and bilirubin, liver size will be measured. | 12 months | Yes |
Secondary | quality of life | Measure changes in quality of life by TB score questionnaire | 12 months | Yes |
Secondary | hematology parameters | Measure CBC by standard routine methods | 12 months | Yes |
Secondary | weight gain | Measure changes in body weight | 12 months | Yes |
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