The First Failure Study (FAST)

March 23, 2015 updated by: Imperial College London

A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects

The purpose of this study is to look at two different antiretroviral treatment options in individuals who are about to commence their second antiretroviral treatment.

This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences include: differences in body fat distribution, in lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking to show differences in body fat distribution between the two study treatment arms. Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive function will also be assessed. There is also a lumbar puncture sub study participants can also take part in.

The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years) plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64, 80 and 96)

Study Overview

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

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

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:

  • HIV-1 infected males or females
  • over 18 years of age
  • signed informed consent
  • currently receiving a stable antiretroviral regimen comprising of:
  • two or more licensed NRTIs
  • one licensed NNRTI or boosted protease inhibitor
  • no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
  • failure of current antiretroviral regimen due to:
  • toxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening
  • toxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA < 400 copies/mL at screening)
  • willing to modify antiretroviral therapy, in accordance with the randomisation assignment
  • no previous exposure to etravirine
  • subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator
  • have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen
  • female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study:
  • barrier contraceptives (condom, diaphragm with spermicide)
  • IUD or Depo PLUS a barrier contraceptive
  • female subjects of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

  • current alcohol abuse or drug dependence
  • pregnancy
  • active opportunistic infection or significant co-morbidities
  • current prohibited concomitant medication
  • a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
Other Names:
  • Truvada
  • Prezista
  • Norvir
Experimental: NRTI sparing arm
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
Other Names:
  • Prezista
  • Norvir
  • Intelence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in peripheral and central adipose tissue
Time Frame: week 48 and 96
As measured by DEXA, between treatment arms.
week 48 and 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients <50 copies HIV-1 RNA/mL
Time Frame: 96 weeks
At all study points to weeks 48 and 96 between treatment arms.
96 weeks
Mean change from baseline of absolute CD4+ T cell count
Time Frame: 96 weeks
between treatment arms
96 weeks
Time to change in randomly assigned therapy
Time Frame: 96 weeks
between treatment arms
96 weeks
Mean change from baseline Lipodystrophy Case Definition score
Time Frame: 96 weeks
Between treatment arms
96 weeks
Mean change from baseline in fasting lipid and glycaemia parameters
Time Frame: 96 weeks
between treatment arms
96 weeks
Mean change from baseline in cardiac and bone biomarker levels
Time Frame: Week 96
between treatment arms
Week 96
• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Time Frame: 96 week s
Between the treatment arms
96 week s
Patterns of genotypic HIV resistance associated with virological treatment failure
Time Frame: 96 weeks
Across the treatment arms
96 weeks
Describe aspects of immune reconstitution disease (IRD)
Time Frame: 96 weeks
Across the treatment arms
96 weeks
Comparison of quality of life and results of adherence questionnaires
Time Frame: 96 weeks
Between the treatment arms
96 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alan Winston, MB ChB, Imperial College London

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

May 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

July 1, 2010

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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