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

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.