- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118871
The First Failure Study (FAST)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- St. Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Experimental: NRTI sparing arm
|
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Alan Winston, MB ChB, Imperial College London
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Darunavir
- Etravirine
Other Study ID Numbers
- FAST1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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