·         OBJECTIVES:

·         To compare clinical, virological and immunological responses to Single daily dose of Nevirapine (400 mg ) versus twice daily dose of Nevirapine (200 mg) -based highly active antiretroviral therapy (HAART) regimens in antiretroviral-naive patients with HIV and Tuberculosis infection on ATT.

·         To determine the safety of Single daily dose of Nevirapine (400 mg) versus twice daily dose of Nevirapine (200 mg)- based highly active antiretroviral therapy regimens in antiretroviral-naive patients with HIV and Tuberculosis infection on ATT.

·         To characterize drug-associated toxicities of Single daily dose of Nevirapine (400 mg) versus twice daily dose of Nevirapine (200 mg) - based regimens in HIV and Tuberculosis patients on ATT (especially hepatic).

·         No conclusive proof from India to demonstrate the safety and efficacy of 400 mg OD Nevirapine based HAART versus 200 mg BD Nevirapine based HAART in HIV TB co-infected patients.

·         Once per day combination of ARV drugs with Nevirapine in the form of single tablet formulation will be low cost, easy to take and will have better adherence.

·         Once per day combination of Tenofovir + Lamivudine / Emtricitabine and Efavirenz in the form of single tablet formulation is already available and very popular, but is costlier.

6.1 No of patients-100.

6.2 Inclusion criteria

       c

     6.3   Exclusion Criteria:

a)               Allergy/sensitivity to any study drug(s).

b)              Prior history of documented drug-resistant TB.

c)               Pregnancy

d)              Patients with alanine aminotransferase or aspartate  aminotransferase levels more than  five  times the upper limit of normal.

e)               Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients                         

f)                Concomitant diabetes mellitus.

g)               Epilepsy

h)              Patients on other immunosuppressive therapy.

i)                 Malignancy other than Kaposi’s Sarcoma requiring therapy.

6.4 Controls- 20 patients of HIV without tuberculosis.

6.5 Study design- A randomized, open-label, prospective study.

6.6 Dosages of drugs-

•    Group I  - 20 patients with once daily dose of Nevirapine (400 mg 1 OD)- based highly active antiretroviral therapy regimen with ATT.

•    Group II - 20 patients with twice daily dose of Nevirapine (200 mg 1 BD) –based highly active antiretroviral therapy  regimen with ATT.

•    Group III - 20 patients with once daily dose of Efavirenz(600 mg 1 OD)- based highly active antiretroviral therapy regimen with ATT.

•    Group IV- 20 patients with once daily dose of Tenofovir (300 mg) +Lamivudine (300 mg 1 OD) and Nevirapine (400 mg 1 OD) – based highly active antiretroviral therapy regimen with ATT.

•    Group V - 20 patients with once daily dose of Nevirapine (400 mg 1 OD)- based highly active antiretroviral therapy regimen without ATT.

6.7 Duration of treatment- 48 weeks,

6.8 Investigations specifically related to project-Serum Nevirapine concentration.

6.9 Permission to use copy righted questionnaire proforma.

       Not using copy righted questionnaire proforma.

6.10 Others- nil.

     6.11 Brief methodology-

A randomized, open-label, prospective study would be carried out. The analysis would be based upon non- inferiority study and observing the HIV virological response at the end of 48 weeks. (N=100 subjects)