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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

February 2, 2010
November 27, 2013
January 2010
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01061593 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tuberculosis
  • HIV
  • Dietary Supplement: Immunoxel
    50 drops twice per day
  • Drug: Placebo
    50 drops twice per day
  • Drug: TB drugs+ Immunoxel
    50 drops twice per day
  • Drug: ATT+Placebo
    50 drops twice per day
  • Drug: ATT + Placebo
    50 drops twice per day
  • Drug: drug-resistant TB on ATT+Immunoxel
    50 drops twice per day
  • Drug: Immunoxel
    TB/HIV patients on ATT + Immunoxel
  • Experimental: ATT+Immunoxel
    Drug-sensitive patients on standard ATT + Immunoxel at 50 drops twice/day
    Interventions:
    • Dietary Supplement: Immunoxel
    • Drug: TB drugs+ Immunoxel
  • Placebo Comparator: ATT+Placebo
    Drug-sensitive patients on standard ATT + Placebo 50 drops twice/day
    Interventions:
    • Drug: Placebo
    • Drug: ATT+Placebo
    • Drug: ATT + Placebo
  • Experimental: drug-resistant TB on ATT + Immunoxel
    Multi-drug resistant TB patients on ATT + Immunoxel 50 drops twice/day
    Intervention: Drug: drug-resistant TB on ATT+Immunoxel
  • Experimental: TB/HIV patients on ATT + Immunoxel
    TB patients with HIV on ATT + Immunoxel 50 drops twice/day
    Intervention: Drug: Immunoxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Ukraine
 
NCT01061593
LRTBD-2259
No
Galyna Kutsyna, Lisichansk Regional Tuberculosis Dispensary
Lisichansk Regional Tuberculosis Dispensary
Ekomed LLC
Principal Investigator: Galyna kutsyna, MD, PhD Ekomed LLC
Lisichansk Regional Tuberculosis Dispensary
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP