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SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over

NCT02509195 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-02-28

No results posted yet for this study

Summary

The purpose of this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir.

These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection.

Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.

The investigators aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.

The study will also assess the quality of life (wellbeing of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.

The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.

Conditions

Interventions

DRUG

Triumeq

Subjects will take the last dose of their current antiretroviral combination at its usual time on the day before the baseline visit (day 1) and will switch on day 1 to Abacavir/lamivudine/dolutegravir 600mg/300mg/50mg (Triumeq) fixed dose combination once daily between day 1 and day 180.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito · St Stephen's AIDS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2017-02-13
Completion
2017-07-24

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02509195 on ClinicalTrials.gov