The First Failure Study (FAST)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01118871
First received: May 6, 2010
Last updated: May 20, 2014
Last verified: July 2010

May 6, 2010
May 20, 2014
May 2010
May 2013   (final data collection date for primary outcome measure)
Mean change from baseline in peripheral and central adipose tissue [ Time Frame: week 48 and 96 ] [ Designated as safety issue: No ]
As measured by DEXA, between treatment arms.
Same as current
Complete list of historical versions of study NCT01118871 on ClinicalTrials.gov Archive Site
  • Percentage of patients <50 copies HIV-1 RNA/mL [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    At all study points to weeks 48 and 96 between treatment arms.
  • Mean change from baseline of absolute CD4+ T cell count [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    between treatment arms
  • Time to change in randomly assigned therapy [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    between treatment arms
  • Mean change from baseline Lipodystrophy Case Definition score [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Between treatment arms
  • Mean change from baseline in fasting lipid and glycaemia parameters [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    between treatment arms
  • Mean change from baseline in cardiac and bone biomarker levels [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
    between treatment arms
  • • Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs [ Time Frame: 96 week s ] [ Designated as safety issue: Yes ]
    Between the treatment arms
  • Patterns of genotypic HIV resistance associated with virological treatment failure [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Across the treatment arms
  • Describe aspects of immune reconstitution disease (IRD) [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
    Across the treatment arms
  • Comparison of quality of life and results of adherence questionnaires [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    Between the treatment arms
Same as current
Not Provided
Not Provided
 
The First Failure Study
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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: Darunavir, Ritonavir, Truvada
    Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
    Other Names:
    • Prezista
    • Norvir
    • Truvada
  • Drug: Darunavir, Ritonavir and Etravirine
    Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
    Other Names:
    • Prezista
    • Norvir
    • Intelence
  • Active Comparator: Standard of care
    Intervention: Drug: Darunavir, Ritonavir, Truvada
  • Experimental: NRTI sparing arm
    Intervention: Drug: Darunavir, Ritonavir and Etravirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01118871
FAST1.0
No
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Alan Winston, MB ChB Imperial College London
Imperial College London
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP