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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 June 2015
• Main ID: NCT01061593
• Date of registration: 02/02/2010
• Prospective Registration: No
• Primary sponsor: Lisichansk Regional Tuberculosis Dispensary
• Public title: Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
• Scientific title: Phase III, Double-blind, Placebo-controlled, Randomized, 1-month Clinical Trial of Immunoxel Combined With Anti-TB Therapy Versus Anti-TB Therapy With Placebo
• Date of first enrolment: January 2010
• Target sample size: 269
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01061593
• 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
• Phase: Phase 3

Countries of recruitment

Mongolia, Ukraine

Contacts

• Name: Galyna kutsyna, MD, PhD
• Affiliation: Ekomed LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who are at least 18 years and are willing and capable of providing informed
consent. Both men and non-pregnant women will be included. One group of at least 30
patients will have HIV. Another group of at least 30 patients will have MDR-TB.
Another group of at least 30 patients will have XDR-TB Remaining patients will have
drug-sensitive TB. They will be randomly assigned to placebo at 1:1 ratio.

- TB infection documented prior to Study Entry by sputum smear positive staining for
acid-fast bacilli (AFB).

- Agreement to participate in the study and to give a sample of blood for HIV testing
if required.

- 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 trials and those without
sufficient 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, 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

HIV

Intervention(s)

Other: Placebo

Dietary Supplement: Immunoxel

Primary Outcome(s)

To compare the efficacy of combination of Immunoxel with anti-TB treatment versus anti-TB treatment with placebo in adults with sputum smear positive pulmonary tuberculosis [Time Frame: 1 month]

Secondary Outcome(s)

To confirm the safety of Immunoxel as demonstrated by Liver functions tests (ALT and bilirubin) and hemoglobin; effect on TB-associated wasting by measuring body weight. Effect on lymphocytes and CD4+ cells, CD4/CD8 ratio among those who have HIV. [Time Frame: 1 month]

Secondary ID(s)

LRTBD-2259

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ekomed LLC