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Renal Integrase Study

NCT02351908 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-27

No results posted yet for this study

Summary

The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment for HIV infection for the first time.

All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by the national guide-lines and used in standard clinical practice.

Conditions

Interventions

DRUG

Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)

DRUG

Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet

DRUG

Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)

Sponsors & Collaborators

Principal Investigators

  • Graeme Moyle, MD, MBBS, Dip GUN · Chelsea and Westminster NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-04-30
Completion
2017-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351908 on ClinicalTrials.gov