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A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine

NCT01701882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-26

No results posted yet for this study

Summary

The purpose of the study is to investigate the benefits of switching away from efavirenz (which patients are taking in combination with Kivexa® or as part of the combination pill, Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty with sleeping}, bad dreams etc). The investigators in this study will investigate the effect of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new component of the combination.

Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time.

This study will also investigate the safety (in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness, your viral load and CD4 counts, when you switch treatment to tenofovir/emtricitabine/rilpivirine.

Conditions

Interventions

DRUG

tenofovir/emtricitabine/rilpivirine

Sponsors & Collaborators

  • St Stephens Aids Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01701882 on ClinicalTrials.gov