A study to see how safe, tolerable & effective Dolutegravir drug is when taken with Tenofovir & Lamivudine inpatients with HIV-1

Phase 4

• Conditions: Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] disease

• Registration Number: CTRI/2019/02/017439
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female, age >= 18 years at the time of signing of an ICF.

2. Confirmed and documented HIV-1 infection, treatment naïve 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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse eventsTimepoint: throughout the study

Secondary Outcome Measures

Name	Time	Method
Change in CD4plus cell count from baselineTimepoint: At the end of the treatment;Proportion of subjects achieving plasma HIV-1 RNA 50 copies/mL in the treatment groupTimepoint: At the end of the treatment