HIV And TB Study

A RANDOMIZED, TWO-ARM, CONTROLLED, OPEN-LABEL STUDY OF ENERCEL® AND STANDARD THERAPY VERSUS ENERCEL® ALONE FOR CO-INFECTION OF DRUG-SENSITIVE, PULMONARY TUBERCULOSIS AND HIV INFECTION WITH CD4 COUNT > 150 cells/ml AND A VIRAL LOAD > 100,000 copies/ml

OVERVIEW:

This is a randomized, two-arm, controlled, open-label trial of a homeopathic formulation, Enercel®, which is to be administered intravenously (IV), intramuscular (IM), sublingual (SL), intranasal and via nebulizer alone or in combination with standard antibiotic and antiretroviral therapy for patients with drug-sensitive tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection with CD4 count > 150 cells/ml and viral load > 100,000 copies/ml. Patients who have been treated with standard therapy alone will act as controls. Subjects must have evidence of an active pulmonary TB infection defined by: documented fever > 37.8° C on at least one occasion, cough and weight loss > 8 kg over the 3 months prior to enrollment. In addition, they must have a Chest X-ray (CXR) and/or chest CT scan with pulmonary infiltrates within the 3 weeks prior to enrollment and a sputum culture positive for Mycobacterium tuberculosis (with sensitivity testing to antituberculosis drugs) within the 3 months prior to enrollment. For the purposes of this study, drug-sensitive TB is defined as complete culture-sensitivity to isoniazid (INH) and rifampin. Standard therapy is defined as: isoniazid, rifampin, pyrazinamide, and ethambutol for two months, then isoniazid and rifampicin alone for a further four months. Streptomycin may be substituted for ethambutol in patients who cannot tolerate it or have resistance. The strain in any given patient must have intermediate or fully sensitive status to each drug used.

In addition, patients must have co-infection with HIV, a viral load > 100,000 copies/ml and a CD4 count > 150 cells/ml. Standard therapy with antiretroviral drugs includes, but is not limited to:

Non-nucleoside reverse transcriptase inhibitors (NNRTIs); efavirenz (Sustiva), etravirine (Intelence) and nevirapine (Viramune).

Nucleoside reverse transcriptase inhibitors (NRTIs); abacavir (Ziagen), and the combination drugs emtricitabine and tenofovir (Truvada), and lamivudine and zidovudine (Combivir).

Protease inhibitors (PIs); atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva) and ritonavir (Norvir).

Entry or fusion inhibitors; enfuvirtide (Fuzeon) and maraviroc (Selzentry).

Integrase inhibitors; raltegravir (Isentress)

 

The study subjects will be voluntary, adult participants who meet criteria for pulmonary TB and HIV co-infection. Both treatment-naïve and prior treatment status are acceptable, but patients with prior treatment must have a 2-week washout period. All patients must have positive TB smears, CD4 count > 150 cells/ml and HIV viral load > 100,000 copies/ml at study onset. The study period will be 3 months. It is anticipated that 20 subjects will be enrolled, 10 in each arm. In addition, there will be 5 control patients on standard therapy alone.

Study group A will receive standard medical treatment for TB and HIV infection as defined  above along with Enercel® on the following schedule. Standard therapy regimens will vary, but once a drug combination is started, it cannot be changed during the 3 month study period. Group B will receive each of the 4 Enercel® products alone for the entire 3 month study period on the same schedule as group A:

  1. Enercel® Plus IV: 50 cc IV twice daily for 30 days; then 50 cc IV once daily for 30 days; then 50 cc IV once daily, M-F, for 30 days
  2. Enercel® Mist Nasal will be given 2 puffs into each nostril three times daily (morning, afternoon and evening without regards to meals)
  3. Enercel® Mist Nebulizer, 7 cc given via nebulizer twice daily
  4. Enercel® Max will be given 20 drops sublingually in the morning and evening

The participants will be monitored biweekly by the Investigators or more often as clinically indicated by adverse events or any problems that, in the opinion of the Investigators, warrants more frequent visits.

Enercel® is a homeopathic formulation that has been used safely and successfully for multiple medical conditions (see Therapeutic Indications in Appendix I as approved by the Ukrainian Regulatory Agencies). It acts primarily through enhancement of membrane potentials and intracellular energy pathways. It has been shown to increase Natural Killer (NK) cell function for in vitro, animal and in small human studies (see Results of Clinical and Animal Efficacy studies of Enercel® in Appendix I) a process that may be important in controlling TB and HIV infections. NK cells are an important group of cells in the innate immune system that kill cells infected with intracellular pathogens like tuberculosis and HIV. Doses up to 50cc IV bid have been used without side-effects or toxicity in over 200 patients.

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