Status:
COMPLETED
Safety and Efficacy of Oral Immunomodulator in Tuberculosis (TB) and TB/HIV Patients
Lead Sponsor:
Lisichansk Regional Tuberculosis Dispensary
Collaborating Sponsors:
National Medical University, Ukraine
Immunitor USA Inc.
Conditions:
Tuberculosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01222338
Start Date
January 1 2010
End Date
January 1 2011
Last Update
August 3 2012
Active Locations (1)
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1
Lisichansk TB Dispensary
Lisichansk, Luhansk Oblast, Ukraine, 20001