HIV InfectionsPhase 4AMICINCT00488059
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
A Phase 4 study testing enfuvirtide [Fuzeon], Optimized background ARV and Integrase inhibitor in people with HIV Infections, run by Hoffmann-La Roche at 43 sites in 2 countries.
Trial summary
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. 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], Optimized background ARV and Integrase inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive
- GSS >= 3 ; nucleosides excluded
Who cannot join
- Adverse clinical or laboratory experience >ACTG Grade 4
- Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen
- Malignancy requiring chemotherapy or radiotherapy
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States41 sites
Study site
Allentown, Pennsylvania, 18102-7017
Study site
Annandale, Virginia, 22003
Study site
Atlanta, Georgia, 30309
Study site
Atlanta, Georgia, 30318
Study site
Boston, Massachusetts, 02215-3318
Study site
Briarcliff Manor, New York, 10510
Study site
Chicago, Illinois, 60657
Study site
Dallas, Texas, 75246
Study site
Fort Lauderdale, Florida, 33307
Study site
Fort Lauderdale, Florida, 33334
Study site
Fort Myers, Florida, 39912
Study site
Fort Worth, Texas, 76104
Study site
Hobson City, Alabama, 36201
Study site
Houston, Texas, 77098
Study site
Kansas City, Missouri, 64111
Study site
Los Angeles, California, 90027
Study site
Los Angeles, California, 90028
Study site
Los Angeles, California, 90036
Study site
Los Angeles, California, 90069
Study site
Macon, Georgia, 31201
Study site
Miami, Florida, 33133
Study site
Miami Beach, Florida, 33139
Study site
Modesto, California, 95350
Study site
New York, New York, 10003
Study site
Newark, New Jersey, 07102
Study site
North Palm Beach, Florida, 33408
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85006
Study site
Plantation, Florida, 33317
Study site
Port Saint Lucie, Florida, 34952
Study site
Reading, Pennsylvania, 19601
Study site
Rochester, New York, 14604
Study site
Safety Harbor, Florida, 36495
Study site
Silver Spring, Maryland, 20910
Study site
South Miami, Florida, 33143
Study site
St Louis, Missouri, 63139
Study site
Stanford, California, 94305
Study site
Tampa, Florida, 33614
Study site
The Bronx, New York, 10467-2490
Study site
Washington D.C., District of Columbia, 20009
About this study
Official title: A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.
- Conditions
- HIV Infections
- Being tested
- enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor
- 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
90 mg SC twice daily
Optimized background ARVDrug
As prescribed
Integrase inhibitorDrug
As prescribed
enfuvirtide [Fuzeon]Drug
180 mg SC once daily
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs). Receives: Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV; Drug: Integrase inhibitor |
| Phase II | Experimental | In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of
(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs. Receives: Drug: Optimized background ARV; Drug: Integrase inhibitor; Drug: enfuvirtide [Fuzeon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
Measured: Between Week I-4 and Week I-12 of Phase I of the study
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
Measured: Week II-16
Secondary outcomes (5)
Virologic Response Over Time in Phase I of the Study
The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.
Measured: Weeks 4, 8 & 12
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 \& LOCF for ITT patients in Phase I of the study
Measured: Baseline and Weeks 4, 8, 12 & LOCF
Virologic Response Over Time in Phase II of the Study
The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.
Measured: Weeks II-4, 8, 12 & 16
CD4+ Lymphocyte Count Change From Baseline
Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.
Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.
Measured: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Measured: Phase I and II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: This study was terminated early due to poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- 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)
- Collaborators
- Trimeris
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488059
- Sponsor's protocol ID
- ML20837
- Acronym
- AMICI
- Status last verified
- Jul 2011
- First submitted
- 18 Jun 2007
- Last updated
- 22 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen
- ClinicalTrials.gov ID
- NCT00488059
- Acronym / sponsor ID
- AMICI / ML20837
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to poor enrollment.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Posted 29 Jun 2011
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 evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: enfuvirtide [Fuzeon], Drug: Optimized background ARV, Drug: Integrase inhibitorPhase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs). |
| Phase II | Experimental | Drug: Optimized background ARV, Drug: Integrase inhibitor, Drug: enfuvirtide [Fuzeon]In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of (Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs. |
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
- Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive
- GSS >= 3 ; nucleosides excluded
Key exclusion criteria (3 listed)
- Adverse clinical or laboratory experience >ACTG Grade 4
- Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen
- Malignancy requiring chemotherapy or radiotherapy
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]90 mg SC twice daily | Drug | Phase I |
| Optimized background ARVAs prescribed | Drug | Phase I, Phase II |
| Integrase inhibitorAs prescribed | Drug | Phase I, Phase II |
| enfuvirtide [Fuzeon]180 mg SC once daily | Drug | Phase II |
Primary outcome
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
Time frame: Between Week I-4 and Week I-12 of Phase I of the study
Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
Time frame: Week II-16
5 secondary outcomes
Virologic Response Over Time in Phase I of the Study
Time frame: Weeks 4, 8 & 12
HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
Time frame: Baseline and Weeks 4, 8, 12 & LOCF
Virologic Response Over Time in Phase II of the Study
Time frame: Weeks II-4, 8, 12 & 16
CD4+ Lymphocyte Count Change From Baseline
Time frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF
Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
Time frame: Phase I and II
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing enfuvirtide [Fuzeon], Optimized background ARV and Integrase inhibitor in people with HIV Infections, run by Hoffmann-La Roche at 43 sites in 2 countries.
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 3 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL (time frame: Between Week I-4 and Week I-12 of Phase I of the study). The study lists 2 primary outcomes in all. 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 22 Jul 2011.