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Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ekomed LLC
Information provided by (Responsible Party):
Galyna Kutsyna, Lisichansk Regional Tuberculosis Dispensary
ClinicalTrials.gov Identifier:
NCT01061593
First received: February 2, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances immunity against viral and infectious diseases. The goal of this study is to conduct confirmatory clinical trial in Ukraine for TB indications.


Condition Intervention Phase
Tuberculosis
HIV
Dietary Supplement: Immunoxel
Drug: Placebo
Drug: TB drugs+ Immunoxel
Drug: ATT+Placebo
Drug: ATT + Placebo
Drug: drug-resistant TB on ATT+Immunoxel
Drug: Immunoxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II, Double-blind, Placebo-controlled, Randomized, 6-months Clinical Trial of Immunoxel Combined With First-line Anti-TB Therapy Versus First-line Anti-TB Therapy With Placebo

Resource links provided by NLM:


Further study details as provided by Lisichansk Regional Tuberculosis Dispensary:

Primary Outcome Measures:
  • To compare the efficacy of combination of Immunoxel with first-line anti-TB treatment versus first-line anti-TB treatment with placebo in adults with sputum smear positive pulmonary tuberculosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To confirm the safety of Immunoxel as demonstrated by Liver functions tests (AST and ALT, and bilirubin) and hemoglobin ; quality of life improvement by Karnofsky Score; effect on TB-associated wasting by measuring body weight. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATT+Immunoxel
Drug-sensitive patients on standard ATT + Immunoxel at 50 drops twice/day
Dietary Supplement: Immunoxel
50 drops twice per day
Drug: TB drugs+ Immunoxel
50 drops twice per day
Placebo Comparator: ATT+Placebo
Drug-sensitive patients on standard ATT + Placebo 50 drops twice/day
Drug: Placebo
50 drops twice per day
Drug: ATT+Placebo
50 drops twice per day
Drug: ATT + Placebo
50 drops twice per day
Experimental: drug-resistant TB on ATT + Immunoxel
Multi-drug resistant TB patients on ATT + Immunoxel 50 drops twice/day
Drug: drug-resistant TB on ATT+Immunoxel
50 drops twice per day
Experimental: TB/HIV patients on ATT + Immunoxel
TB patients with HIV on ATT + Immunoxel 50 drops twice/day
Drug: Immunoxel
TB/HIV patients on ATT + Immunoxel

Detailed Description:

Phase II, placebo-controlled trial, aimed to seek the therapeutic benefit of Immunoxel in combination with standard of care first-line anti-TB therapy (ATT) at the end of the 6 months period (p<0.05) among subjects with sputum-positive pulmonary TB. The results will be compared to standard first-line ATT therapy + placebo. The trial will consist of one stage with laboratory evaluation at months 2 and 6. Four cohorts or arms of at least 30 subjects each (total 120) with pulmonary TB positive for sputum AFB smear will be randomized in a 1:1:1:1 ratio to receive once-daily, 50-drop dose of Immunoxel in combination with standard ATT for 6 months. Patients who receive standard ATT + placebo preparation will be used as a group of comparison.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are at least 18 years but less than 60 years 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 MDR-TB. 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.
  • Women of child-bearing potential must have a negative serum or urine beta-hCG test result, as determined by a pregnancy test. All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
  • Satisfactory Karnofsky performance status score.
  • Agreement to participate in the study and to give a sample of blood for HIV testing.
  • Readily available home or other address where patient can be easily found at follow-up studies.

Exclusion Criteria:

  • Subjects who have already taken Immunoxel 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.
  • History of angina, cardiac arrhythmias, clinically significant electrocardiogram abnormalities, or congestive heart failure. Evidence of active or acute cardiac disease, concomitant hypertension, diabetes mellitus, epilepsy, or serious forms of extra-pulmonary tuberculosis.
  • History of malignancy, other than minimal Kaposi sarcoma or other localized skin cancer (e.g. <10 cutaneous lesions, no evidence of visceral KS, etc.), or who have had prior cancer chemotherapy.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061593

Locations
Ukraine
Lisichansk Regional TB Dispensary
Lisichansk, Luhansk region, Ukraine, 93106
Sponsors and Collaborators
Lisichansk Regional Tuberculosis Dispensary
Ekomed LLC
Investigators
Principal Investigator: Galyna kutsyna, MD, PhD Ekomed LLC
  More Information

Additional Information:
Publications:
Responsible Party: Galyna Kutsyna, PI, Lisichansk Regional Tuberculosis Dispensary
ClinicalTrials.gov Identifier: NCT01061593     History of Changes
Other Study ID Numbers: LRTBD-2259
Study First Received: February 2, 2010
Last Updated: November 27, 2013
Health Authority: Ukraine: Ethics Committee

Keywords provided by Lisichansk Regional Tuberculosis Dispensary:
TB
MDR-TB
XDR-TB
TB/HIV

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 27, 2014