Health Condition 1: B20-B20- Human immunodeficiency virus [HIV] disease
Conditions
Interventions
Intervention1: Dolutegravir (50 mg once daily) with Tenofovir & Lamivudine 300/300 mg: Dose: 50 mg
Frequency: Once daily
Route of administration: Oral
Duration of treatment: 20 weeks
Control Intervent
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse eventsTimepoint: throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed