Multicenter, non-randomized, non-controlled, open-label Phase IV trial to evaluate the safety, tolerability and effectiveness of Dolutegravir 50 mg tablet of Emcure Pharmaceuticals along with other antiretrovirals among HIV-1 infected subjects.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 8
- 主要终点
- Safety
研究概览
简要总结
The primary purpose of this phase 4 study is to assess the safety and tolerability of Tab. Dolutegravir 50mg in HIV 1 infected individuals who are either ART naïve or on treatment with viral load less than 50 copies/ml or ART failure with viral load more than 50 copies/ml. This study would be multicentric , non randomized and open label trial with a aim to recruit 275 patients as per DCGI recommendation.
We would calculate the incidence rates of adverse events ,lab abnormalities and do causality assessment using WHO UMC scale and NARANJO SCALE.
The participants would be evaluated with neuropsychiatric symptom questionnaire during the baseline and during next 4 visits in the six months follow up of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •HIV 1 infected Subjects Willing and able to understand and provide signed and dated written informed consent after screening.
- •18 years or older, and adults with weight more than 40 kgs.
- •HIV-1 positive Subjects who are either.
- •ART naïve Treatment experienced with NRTI’s, NNRTI’s , PI and Raltegravir based regimen with Viral load less than 50 copies/ml Subjects with ART failure having Viral load more than 50 copies/ml General medical condition does not interfere with trial procedures Females are eligible if: They do not plan to become pregnant during the study and next 18 months after baseline Negative screening pregnancy test and uses one of the following methods: Abstinence from penile/vaginal intercourse during the study Double contraceptive methods of which one must be barrier (condom).
排除标准
- •Known hypersensitivity to any of the Anti-retrovirals drugs or components of Dolutegravir based regimen.
- •Pulmonary tuberculosis and or Extrapulmonary tuberculosis on treatment.
- •Creatinine clearance less than 30mL per min determined using Cockcroft and Gault formula.
- •Hepatic impairment of Child Pugh B C.
- •Treatment with Radiation therapy, cancer chemotherapy or immunomodulator within 28 days of Screening.
- •Any preexisting psychiatric conditions: depression, bipolar disorders, schizophrenia.
- •Pregnant and Lactating HIV-1 infected subjects.
- •Unwilling to give consent for audio recording and unwilling to participate in the study.
- •Any other Contraindications of the other antiretroviral drugs to be used as backbone therapy.
结局指标
主要结局
Safety
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Incidence rate of AE_ADVERSE EVENTS_ by system organ class and severity
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Frequency and severity of AE_ Clinical and Lab abnormalities
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Intention to treat analysis
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Tolerability
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Number of subjects who discontinue the study treatment due to AE
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Assessed by comparing AE profile among subjects given twice daily vs single dose of dolutegravir and among those with advanced immunosuppression
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
Analysis of time to discontinuation of antiretroviral regimen due to any AE
时间窗: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. | Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months
次要结局
- effectiveness as measured trends in change of viral load