Health Condition 1: null- HIV and Tuberculosis
Conditions
Interventions
Intervention1: Once daily dose of Nevirapine (400 mg) versus twice daily dose (200 mg) of Nevirapine â?? based Highly Active Antiretroviral therapy regimens in Antiretroviral â??naïve patients with H
Sponsors
NACO
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria a) HIV infection, documented licensed ELISA test kit. b) Anti tuberculosis treatment (ATT) with standard therapy according to guidelines for less than 14 days. c) Upper limit of CD4+ cell count will be as per NACO guidelines. The lower limit of CD4+ cell count will be more than 50 cells. d) The following laboratory values obtained within 30 days prior to or at study entry. • Absoluteneutrophil count (ANC) more than 500 cells/mm3. • Hemoglobinï?³ 8.0 g/dL. • Platelet count more than 50,000/mm3. • Creatinine less than3 x ULN. • AST (SGOT), ALT (SGPT), alkaline phosphatase less than 5 times ULN. • Total bilirubin less than 2.5 x ULN. e) Female subjects of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days before or at study entry. Male and female subjects who are participating in sexual activity that could lead to pregnancy must agree to use reliable methods of contraception. f) Men and women age more than 18 years. g)Ability and willingness of subject or legalguardian/representative to give written informed consent. h) ARV treatment naïve. i) Focus on both Pulmonary and extra pulmonary TB cases will be included in study as per RNTCP guidelines.
Exclusion criteria
Exclusion criteria: 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 Kaposiâ??s Sarcoma requiring therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV VIROLOGICAL response at 48 weeks(CD4 count)Timepoint: HIV VIROLOGICAL response at 48 weeks(CD4 count) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary end points of the study were defined by safety and tolerability of ARV therapy, as assessed by the incidence of adverse events and proportion of subjects changing/ discontinuing ARV therapy because of the same.Timepoint: 48 weeks | — |
Countries
India
Contacts
Public ContactSANJEEV SINHA
AIIMS, ANSARI NAGAR,
Outcome results
None listed