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

Phase 4

Recruiting

• Conditions: Human immunodeficiency virus [HIV] disease,

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

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-15
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 250

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 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).
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	throughout the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Anu Hospitals; 🇮🇳 Krishna, ANDHRA PRADESH, India

Care Institute of Medical Sciences (CIMS) Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Deenanath Mangeshkar Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Guntur Government General Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Kasturba Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

KLES DR Prabhakar Kore Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Lata Mangeshkar Multispecialty Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Maulana Azad Medical College and Associated Lok Nayak, Govind Ballab Pant Hospital,; 🇮🇳 Delhi, DELHI, India

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Anu Hospitals

🇮🇳Krishna, ANDHRA PRADESH, India

Dr T Jayaprakash

Principal investigator

9440668304

docjapee@rediffmail.com