The First Failure Study (FAST)
This study has been terminated.
Sponsor:
Imperial College London
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
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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:
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
| Enrollment: | 3 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (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:
|
| Experimental: NRTI sparing arm |
Drug: Darunavir, Ritonavir and Etravirine
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
Other Names:
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118871
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118871
Locations
| United Kingdom | |
| St. Mary's Hospital | |
| 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: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01118871 History of Changes |
| Other Study ID Numbers: | FAST1.0 |
| Study First Received: | May 6, 2010 |
| Last Updated: | May 20, 2014 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
|
Treatment experienced |
Additional relevant MeSH terms:
|
Darunavir Ritonavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents |
Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015