Once daily dose of Nevirapine (400 mg) versus twice daily dose (200 mg) of Nevirapine – based Highly Active Antiretroviral therapy regimens in Antiretroviral –naïve patients with HIV and Tuberculosis infection in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NACO
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HIV VIROLOGICAL response at 48 weeks(CD4 count)
研究概览
简要总结
| · OBJECTIVES**:xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /** |
· 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
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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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 62.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •â€¢Absoluteneutrophil count (ANC) more than 500 cells/mm
- •â€¢Hemoglobin 8.0 g/dL.
- •â€¢Platelet count more than 50,000/mm
- •â€¢Creatinine less than3 x ULN.
- •â€¢AST (SGOT), ALT (SGPT), alkaline phosphatase less than 5 times ULN.
- •â€¢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.
排除标准
- •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.
结局指标
主要结局
HIV VIROLOGICAL response at 48 weeks(CD4 count)
时间窗: HIV VIROLOGICAL response at 48 weeks(CD4 count)
次要结局
- 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.(48 weeks)