HIVPhase 4FASTNCT01118871
The First Failure Study
A Phase 4 study testing Darunavir, Ritonavir, Truvada and Darunavir, Ritonavir and Etravirine in people with HIV and HIV Infections, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Darunavir, Ritonavir, Truvada and Darunavir, Ritonavir and Etravirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- HIV, HIV Infections
- Being tested
- Darunavir, Ritonavir, Truvada, Darunavir, Ritonavir and Etravirine
- Keywords
- Treatment experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir, Ritonavir, TruvadaDrug
Also called Prezista, Norvir, Truvada
Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
Darunavir, Ritonavir and EtravirineDrug
Also called Prezista, Norvir, Intelence
Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Not described Receives: Drug: Darunavir, Ritonavir, Truvada |
| NRTI sparing arm | Experimental | Not described Receives: Drug: Darunavir, Ritonavir and Etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in peripheral and central adipose tissue
As measured by DEXA, between treatment arms.
Measured: week 48 and 96
Secondary outcomes (10)
Percentage of patients <50 copies HIV-1 RNA/mL
At all study points to weeks 48 and 96 between treatment arms.
Measured: 96 weeks
Mean change from baseline of absolute CD4+ T cell count
between treatment arms
Measured: 96 weeks
Time to change in randomly assigned therapy
between treatment arms
Measured: 96 weeks
Mean change from baseline Lipodystrophy Case Definition score
Between treatment arms
Measured: 96 weeks
Mean change from baseline in fasting lipid and glycaemia parameters
between treatment arms
Measured: 96 weeks
Mean change from baseline in cardiac and bone biomarker levels
between treatment arms
Measured: Week 96
• Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs
Between the treatment arms
Measured: 96 week s
Patterns of genotypic HIV resistance associated with virological treatment failure
Across the treatment arms
Measured: 96 weeks
Describe aspects of immune reconstitution disease (IRD)
Across the treatment arms
Measured: 96 weeks
Comparison of quality of life and results of adherence questionnaires
Between the treatment arms
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Winston, MB ChB, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118871
- Sponsor's protocol ID
- FAST1.0
- Acronym
- FAST
- Status last verified
- Jul 2010
- First submitted
- 6 May 2010
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT01118871
- Acronym / sponsor ID
- FAST / FAST1.0
- Conditions
- HIV, HIV Infections
- Keywords
- Treatment experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Darunavir, Ritonavir, Truvada |
| NRTI sparing arm | Experimental | Drug: Darunavir, Ritonavir and Etravirine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darunavir, Ritonavir, TruvadaAlso: Prezista, Norvir, TruvadaDarunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily | Drug | Standard of care |
| Darunavir, Ritonavir and EtravirineAlso: Prezista, Norvir, IntelenceDarunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily | Drug | NRTI sparing arm |
Primary outcome
Mean change from baseline in peripheral and central adipose tissue
Time frame: week 48 and 96
As measured by DEXA, between treatment arms.
10 secondary outcomes
Percentage of patients <50 copies HIV-1 RNA/mL
Time frame: 96 weeks
Mean change from baseline of absolute CD4+ T cell count
Time frame: 96 weeks
Time to change in randomly assigned therapy
Time frame: 96 weeks
Mean change from baseline Lipodystrophy Case Definition score
Time frame: 96 weeks
Mean change from baseline in fasting lipid and glycaemia parameters
Time frame: 96 weeks
Mean change from baseline in cardiac and bone biomarker levels
Time frame: 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
Patterns of genotypic HIV resistance associated with virological treatment failure
Time frame: 96 weeks
Describe aspects of immune reconstitution disease (IRD)
Time frame: 96 weeks
Comparison of quality of life and results of adherence questionnaires
Time frame: 96 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Winston, MB ChB principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darunavir, Ritonavir, Truvada and Darunavir, Ritonavir and Etravirine in people with HIV and HIV Infections, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in peripheral and central adipose tissue (time frame: week 48 and 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.