HIV1 InfectionAMPHORENCT00937729
Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment With Enfuvirtide (Fuzeon) Associated With Two Active Molecules
An observational study of HIV1 Infection and HIV Infections, run by University Hospital, Rouen at 1 site in France.
Trial summary
In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV1 Infection, HIV Infections
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Dec 2011
- Phase
- Observational
- 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
Study population: All patients HIV1 infected in virological failure (viral load > 50 copies/ml) by lack of compliance,old of more than 18 years, who never received enfuvirted and without opportunistic infection, yet treated by almost one molecule of each group.
Who may be able to join
- virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.
Who cannot join
- hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules
In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.
- Conditions
- HIV1 Infection, HIV Infections
- Keywords
- uncompliant patients with virological failure, 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.
| Study group | Role | What they receive |
|---|---|---|
| enfuvirtide | all patients would received enfuvirtide and and optimised background |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral load compliance
Measured: one year
Secondary outcomes (1)
statistical analysis of MOS HIV
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2011
- Study completionDec 2011
Why it stopped: difficult to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV1 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- BORSA-LEBAS Françoise, Principal investigator, CHU Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937729
- Sponsor's protocol ID
- 2008/122/HP
- Acronym
- AMPHORE
- Status last verified
- Feb 2012
- First submitted
- 10 Jul 2009
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules
- ClinicalTrials.gov ID
- NCT00937729
- Acronym / sponsor ID
- AMPHORE / 2008/122/HP
- Conditions
- HIV1 Infection, HIV Infections
- Keywords
- uncompliant patients with virological failure, Treatment experienced
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficult to include patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jul 2009 (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.
In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enfuvirtide | – | –all patients would received enfuvirtide and and optimised background |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients HIV1 infected in virological failure (viral load > 50 copies/ml) by lack of compliance,old of more than 18 years, who never received enfuvirted and without opportunistic infection, yet treated by almost one molecule of each group.
Key inclusion criteria (1 listed)
- virological failure, more than 18 years, prouved lack of compliance, with no sub-optimal treatment, in ambulatory status.
Key exclusion criteria (1 listed)
- hospitalization,HIV2 infection,pregnancy,preliminary treatment with enfuvirtide,chimiotherapy , opportunistic infection in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
viral load compliance
Time frame: one year
1 secondary outcome
statistical analysis of MOS HIV
Time frame: one year
Results and safety
The study was stopped early (reason given: difficult to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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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.
BORSA-LEBAS Françoise principal investigator
CHU Hôpitaux de Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV1 Infection and HIV Infections, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 1 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 16 Feb 2012. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: difficult to include patients). 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?
viral load compliance (time frame: one year). 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 16 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.