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The First Failure Study (FAST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01118871
First received: May 6, 2010
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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)


Condition Intervention Phase
HIV
HIV Infections
 Drug: Darunavir, Ritonavir, Truvada
Drug: Darunavir, Ritonavir and Etravirine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 44
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care 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
Experimental: NRTI sparing arm Drug: Darunavir, Ritonavir and Etravirine
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
Other Names:
  • Prezista
  • Norvir
  • Intelence

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118871

Contacts
Contact: Ken Legg, BSc +44 (0)20 3312 1464 k.legg@imperial.ac.uk
Contact: Alan Winston, MBChB +44 (0)20 3312 1603 a.winston@imperial.ac.uk

Locations
United Kingdom
St. Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alan Winston, MB ChB Imperial College London
  More Information

No publications provided

Responsible Party: Gary Roper, Imperial College London
ClinicalTrials.gov Identifier: NCT01118871     History of Changes
Other Study ID Numbers: FAST1.0
Study First Received: May 6, 2010
Last Updated: July 6, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
 Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013