CTRI/2019/02/017439RecruitingPhase 4
An Open-label, Multicenter, Prospective, Phase-IV, Interventional Study to Evaluate the Safety, Tolerability & Efficacy of Dolutegravir (50 mg once daily) in Treatment Naïve Adult Indian Subjects Infected with HIV-1, Eligible to Receive Dolutegravir with Tenofovir & Lamivudine
Mylan Laboratories Limited14 sites in 1 country250 target enrollmentStarted: February 15, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Mylan Laboratories Limited
- Enrollment
- 250
- Locations
- 14
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
This study is an Open-label, Multicenter, Prospective,Phase-IV, Interventional Study to Evaluate the Safety, Tolerability & Efficacyof Dolutegravir (50 mg once daily) in Treatment Naïve Adult Indian SubjectsInfected with HIV-1, Eligible to Receive Dolutegravir with Tenofovir &Lamivudine.
The Primaryobjective of the study is to assess the safety and tolerability of Dolutegravirin adult Indian subjects infected with HIV-1. The Secondary objective of thestudy is to assess the efficacy of Dolutegravir in adult Indian subjectsinfected with HIV-1.
The primaryendpoint is the incidence of adverse events during the study and the secondaryendpoint is the Proportion of subjects achieving plasma HIV-1 RNA < 50copies/mL in the treatment group at the end of treatment (Week 24) and changein CD4+ cell count from baseline to the end of treatment (Week 24).
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female, age ≥ 18 years at the time of signing of an ICF.
- •Confirmed and documented HIV-1 infection, treatment naïve and eligible to receive Dolutegravir with Tenofovir and Lamivudine.
- •Screening ECG without clinically significant abnormalities.
- •Weight > 40 Kgs.
- •Willing and able to provide written informed consent and agreeable to comply with protocol requirement.
- •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.
- •Males and females following adequate contraception.
Exclusion Criteria
- •Pregnant or nursing female.
- •Previous or current AIDS defining illness.
- •Any uncontrolled opportunistic infection or malignancy.
- •Inadequate neutrophil count and platelet count
- •Subjects with inadequate hemoglobin
- •Documented or known clinically-relevant drug or alcohol abuse
- •Subjects with renal and liver impairment
- •Subjects on medicinal products which are contraindicated to be used with Dolutegravir, Tenofovir and Lamivudine (other approved ARV drugs).
- •Subjects having arrhythmia, wherein administration of Dofetilide is required.
- •History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
- •History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- •Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients, as applicable.
- •Subject is unable to follow study instructions and comply with the protocol in the opinion of the investigator.
- •Any other condition as per the physician’s discretion that would make the subjects ineligible for the study.
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: throughout the study
Secondary Outcomes
- Proportion of subjects achieving plasma HIV-1 RNA 50 copies/mL in the treatment group(At the end of the treatment)
- Change in CD4plus cell count from baseline(At the end of the treatment)
Investigators
Study Sites (14)
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