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

July 24, 2017 updated by: St Stephens Aids Trust

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SW10 9TH
        • St Stephen's AIDS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient volunteers who meet all of the following criteria are eligible for this trial:

    1. Is male or female aged 18 years or above
    2. Has HIV-1 infection documented in their medical notes
    3. Has signed the Informed Consent Form voluntarily
    4. Is willing to comply with the protocol requirements
    5. Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz
    6. Has an HIV-plasma viral load at screening <50 copies/mL (single re-test allowed)
    7. Has a CD4 cell count at screening >50 cells/mm3
    8. Estimated glomerular filtration rate (MDRD) >50 ml/min.
    9. Has symptomatic CNS related toxicity associated with EFV
    10. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
    11. If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit

      Exclusion Criteria:

  • Patients meeting 1 or more of the following criteria cannot be selected:

    1. Infected with HIV-2
    2. Using any concomitant therapy disallowed as per SPC for the study drugs (note acid-reducing agents and interaction with rilpivirine)
    3. Has acute viral hepatitis including, but not limited to, A, B, or C
    4. Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
    5. Any investigational drug within 30 days prior to the trial drug administration
    6. Has received rilpivirine in the past
    7. Any clinical evidence of baseline resistance mutations
    8. Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
    9. Severe hepatic impairment
    10. Moderate or severe renal impairment (creatinine clearance < 50ml/min)
    11. If female, she is pregnant or breastfeeding
    12. Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
    13. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tenofovir/emtricitabine/rilpivirine
A one pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of toxicity after 12 weeks
Time Frame: 12 weeks
To investigate whether switching individuals with intolerance to efavirenz-containing cART (as Atripla or Kivexa plus Efavarinz) to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 12 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of toxicity after 24 weeks
Time Frame: 24 weeks
To investigate whether switching to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 24 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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