Back to resultsThe First Failure Study (FAST)
Primary Purpose
HIV, HIV Infections
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Darunavir, Ritonavir, Truvada
Darunavir, Ritonavir and Etravirine
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring Treatment experienced
Eligibility 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
Sites / Locations
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
NRTI sparing arm
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline in peripheral and central adipose tissue
As measured by DEXA, between treatment arms.
Secondary Outcome Measures
Percentage of patients <50 copies HIV-1 RNA/mL
At all study points to weeks 48 and 96 between treatment arms.
Mean change from baseline of absolute CD4+ T cell count
between treatment arms
Time to change in randomly assigned therapy
between treatment arms
Mean change from baseline Lipodystrophy Case Definition score
Between treatment arms
Mean change from baseline in fasting lipid and glycaemia parameters
between treatment arms
Mean change from baseline in cardiac and bone biomarker levels
between treatment arms
• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Between the treatment arms
Patterns of genotypic HIV resistance associated with virological treatment failure
Across the treatment arms
Describe aspects of immune reconstitution disease (IRD)
Across the treatment arms
Comparison of quality of life and results of adherence questionnaires
Between the treatment arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118871
Brief Title
The First Failure Study
Acronym
FAST
Official Title
A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
Treatment experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Title
NRTI sparing arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Darunavir, Ritonavir, Truvada
Other Intervention Name(s)
Prezista, Norvir, Truvada
Intervention Description
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
Intervention Type
Drug
Intervention Name(s)
Darunavir, Ritonavir and Etravirine
Other Intervention Name(s)
Prezista, Norvir, Intelence
Intervention Description
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
Primary Outcome Measure Information:
Title
Mean change from baseline in peripheral and central adipose tissue
Description
As measured by DEXA, between treatment arms.
Time Frame
week 48 and 96
Secondary Outcome Measure Information:
Title
Percentage of patients <50 copies HIV-1 RNA/mL
Description
At all study points to weeks 48 and 96 between treatment arms.
Time Frame
96 weeks
Title
Mean change from baseline of absolute CD4+ T cell count
Description
between treatment arms
Time Frame
96 weeks
Title
Time to change in randomly assigned therapy
Description
between treatment arms
Time Frame
96 weeks
Title
Mean change from baseline Lipodystrophy Case Definition score
Description
Between treatment arms
Time Frame
96 weeks
Title
Mean change from baseline in fasting lipid and glycaemia parameters
Description
between treatment arms
Time Frame
96 weeks
Title
Mean change from baseline in cardiac and bone biomarker levels
Description
between treatment arms
Time Frame
Week 96
Title
• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Description
Between the treatment arms
Time Frame
96 week s
Title
Patterns of genotypic HIV resistance associated with virological treatment failure
Description
Across the treatment arms
Time Frame
96 weeks
Title
Describe aspects of immune reconstitution disease (IRD)
Description
Across the treatment arms
Time Frame
96 weeks
Title
Comparison of quality of life and results of adherence questionnaires
Description
Between the treatment arms
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Winston, MB ChB
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
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The First Failure Study
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