HIV InfectionsPhase 2NCT00615134
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.
A Phase 2 study testing enfuvirtide [Fuzeon] and Optimized background ARV therapy in people with HIV Infections, run by Hoffmann-La Roche at 30 sites in France.
Trial summary
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- enfuvirtide [Fuzeon] and Optimized background ARV therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 30 sitesFrance
- Study dates
- Jan 2008to Jun 2011
- Phase
- Phase 2
- 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
- adult patients, >=18 years of age;
- HIV-1 infection, with virologic failure;
- on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL;
- Fuzeon-naive.
Who cannot join
- coinfection with HIV-2;
- active opportunistic infection in 4 weeks prior to screening;
- cirrhosis or severe liver failure;
- severe renal disease.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Study site
Aulnay-sous-Bois, 93600
Study site
Basse-terre, 97100
Study site
Bordeaux, 33000
Study site
Boulogne, 62321
Study site
Caen, 14033
Study site
Colmar, 68024
Study site
Fort-de-france, 97261
Study site
Garches, 92380
Study site
La Roche-sur-Yon, 85925
Study site
Le Kremlin-Bicêtre, 91275
Study site
Levallois-Perret, 92309
Study site
Lyon, 69317
Study site
Marseille, 13006
Study site
Nantes, 44035
Study site
Nice, 06202
Study site
Nîmes, 30029
Study site
Paris, 75010
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Paris, 75674
Study site
Paris, 75970
Study site
Pessac, 33600
Study site
Pointe à Pitre, 97159
Study site
Poitiers, 86021
Study site
Pontoise, 95303
Study site
Rouen, 73031
Study site
Saint-Denis, 97400
Study site
Saint-Pierre, 97448
Study site
Toulouse, 31052
Study site
Tourcoing, 59208
About this study
Official title: A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon
+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.
- twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.
- Conditions
- HIV Infections
- Being tested
- enfuvirtide [Fuzeon], Optimized background ARV therapy
- 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.
enfuvirtide [Fuzeon]Drug
90mg sc bid
Optimized background ARV therapyDrug
As prescribed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV therapy |
| 2 | Active comparator | Not described Receives: Drug: Optimized background ARV therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with plasma viral load <50 copies/mL
Measured: Week 24
Secondary outcomes (1)
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615134
- Sponsor's protocol ID
- ML21287
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2008
- Last updated
- 27 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.
- ClinicalTrials.gov ID
- NCT00615134
- Acronym / sponsor ID
- ML21287
- Conditions
- HIV Infections
- Keywords
- treatment experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Feb 2008 (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.
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon
+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.
- twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: enfuvirtide [Fuzeon], Drug: Optimized background ARV therapy |
| 2 | Active comparator | Drug: Optimized background ARV therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >=18 years of age;
- HIV-1 infection, with virologic failure;
- on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL;
- Fuzeon-naive.
Key exclusion criteria (4 listed)
- coinfection with HIV-2;
- active opportunistic infection in 4 weeks prior to screening;
- cirrhosis or severe liver failure;
- severe renal disease.
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 |
|---|---|---|
| enfuvirtide [Fuzeon]90mg sc bid | Drug | 1 |
| Optimized background ARV therapyAs prescribed | Drug | 1, 2 |
Primary outcome
Percentage of patients with plasma viral load <50 copies/mL
Time frame: Week 24
1 secondary outcome
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
Related trials for HIV Infections
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
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.
Clinical Trials study director
Hoffmann-La Roche
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing enfuvirtide [Fuzeon] and Optimized background ARV therapy in people with HIV Infections, run by Hoffmann-La Roche at 30 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with plasma viral load <50 copies/mL (time frame: Week 24). 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 27 Jan 2015.