An Open-label, Multicenter, Prospective, Phase-IV, Interventional Study to Evaluate the Safety, Tolerability & Efficacy of Dolutegravir (50 mg once daily) in Treatment NaÃ¯ve Adult Indian Subjects Infected with HIV-1, Eligible to Receive Dolutegravir with Tenofovir & Lamivudine

Mylan Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female, age >= 18 years at the time of signing of an ICF.
•2. Confirmed and documented HIV-1 infection, treatment naÃ¯ve and eligible to receive Dolutegravir with Tenofovir and Lamivudine.
•3. Screening ECG without clinically significant abnormalities.
•4. Weight > 40 Kgs.
•5. Willing and able to provide written informed consent and agreeable to comply with protocol requirement.
•6. Subject has not been treated with any investigational drug or device within 30 days or 5 half-lives of investigational drug, whichever is longer, of the screening visit.
•7. Males and females following adequate contraception

•1. Pregnant or nursing female.
•2. Previous or current AIDS defining illness.
•3. Any uncontrolled opportunistic infection or malignancy.
•4. Inadequate neutrophil count and platelet count
•5. Subjects with inadequate hemoglobin
•6. Documented or known clinically-relevant drug or alcohol abuse
•7. Subjects with renal and liver impairment
•8. Subjects on medicinal products which are contraindicated to be used with Dolutegravir, Tenofovir and Lamivudine (other approved ARV drugs).
•9. Subjects having arrhythmia, wherein administration of Dofetilide is required.
•10. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
•11. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
•12. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
•13. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients, as applicable.
•14. Subject is unable to follow study instructions and comply with the protocol in the opinion of the investigator.
•15. Any other condition as per the physicianâ??s discretion that would make the subjects ineligible for the study.

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