HIV InfectionsPhase 4NCT00232908

QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

A Phase 4 study testing ARV regimen and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 106 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV Infections
What is being tested?: ARV regimen and enfuvirtide [Fuzeon]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 361 participants
Where: 106 sitesin 2 countries
Study dates: Jun 2004to Oct 2005
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

adults or adolescents at least 16 years of age;
HIV-1 infection;
clinically stable, treatment-experienced;
evidence of HIV-1 replication despite ongoing antiretroviral therapy;
CD4 + count greater than 50 cells/mm3.

Who cannot join

previous use of Fuzeon and/or T-1249;
active, untreated opportunistic infection;
inability to self-inject, unless a reliable caregiver is available to inject.

Trial locations and contacts

106 sites in 2 countries.

Country

City, postcode or hospital

106 sites in 2 countries

United States103 sites

Study site
Akron, Ohio, 44304
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30309
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Atlanta, Georgia, 30312
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Atlanta, Georgia, 30318
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Atlanta, Georgia, 30327
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Atlanta, Georgia, 30342
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Austin, Texas, 78705
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Bakersfield, California, 93301
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Bay Pines, Florida, 33744
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Berkeley, California, 94705
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Berkley, Michigan, 48072-1550
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Boise, Idaho, 83704
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Boynton Beach, Florida, 33426
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Brandon, Florida, 33511
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Butte, Montana, 59701
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Charleston, South Carolina, 29425
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45206
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Columbia, South Carolina, 29203
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Dallas, Texas, 75219
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Dallas, Texas, 75246
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Daytona Beach, Florida, 32117
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Decatur, Georgia, 30033
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East Orange, New Jersey, 07018
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Englewood, New Jersey, 07631
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Fairfax, Virginia, 22030
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Fort Lauderdale, Florida, 33311
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Fort Lauderdale, Florida, 33316
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Fort Lauderdale, Florida, 33334
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Fort Myers, Florida, 33901
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Fort Worth, Texas, 76104
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Galveston, Texas, 77555
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Hampton, Virginia, 23666
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Harrisburg, Pennsylvania, 17110
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Houston, Texas, 77004
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Houston, Texas, 77027
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Houston, Texas, 77098
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Jacksonville, Florida, 32204
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Jacksonville, Florida, 32206
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Jersey City, New Jersey, 07302
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Kansas City, Missouri, 64111
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Kansas City, Missouri, 64112
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Las Vegas, Nevada, 89102
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Lawrenceville, Georgia, 30045
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Los Angeles, California, 90022
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Los Angeles, California, 90026
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Los Angeles, California, 90073
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Louisville, Kentucky, 40202
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Manhasset, New York, 11030
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Miami, Florida, 33137
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Miami Beach, Florida, 33139
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Miami Beach, Florida, 33140
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Minneapolis, Minnesota, 55404
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Modesto, California, 95350
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Mount Vernon, New York, 10550
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New York, New York, 10011
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New York, New York, 10016
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Newark, New Jersey, 07102
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Newark, New Jersey, 07103
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Newark, New Jersey, 07112
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North Palm Beach, Florida, 33408
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Oakland, California, 94609
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Oakland Park, Florida, 33334
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Orlando, Florida, 32806
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Palm Springs, California, 92262
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Perth Amboy, New Jersey, 08861
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85012
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Plantation, Florida, 33317
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Pompano Beach, Florida, 33062
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Port Saint Lucie, Florida, 34952
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Portland, Oregon, 97209-2534
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Rancho Mirage, California, 92270
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Reading, Pennsylvania, 19601
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Rochester, New York, 14604
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San Antonio, Texas, 78212
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San Mateo, California, 94403
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Sarasota, Florida, 34239
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Seattle, Washington, 98104
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Seattle, Washington, 98109
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Silver Spring, Maryland, 20910
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Somers Point, New Jersey, 08244
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South Miami, Florida, 33143
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Springfield, Illinois, 62703
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St Louis, Missouri, 63108
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St Louis, Missouri, 63117
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St Louis, Missouri, 63139
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Staten Island, New York, 10304
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Stony Brook, New York, 11794-8153
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Tallahassee, Florida, 32308
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Tamarac, Florida, 33321
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Tampa, Florida, 33607
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Tampa, Florida, 33614
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Tarzana, California, 91356
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Topeka, Kansas, 66606
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Vero Beach, Florida, 32960
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Washington D.C., District of Columbia, 20017
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West Orange, New Jersey, 07052
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West Reading, Pennsylvania, 19611
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Wichita, Kansas, 67214
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Winston-Salem, North Carolina, 27103
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Ypsilanti, Michigan, 48197

Other trials in United States

Puerto Rico3 sites

Study site
Cagaus, 00725
Study site
Ponce, 00717-1563
Study site
San Juan, 00908

Other trials in Puerto Rico

About this study

Official title: An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection

This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions: HIV Infections
Being tested: ARV regimen, enfuvirtide [Fuzeon]
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ARV regimenDrug
As prescribed
enfuvirtide [Fuzeon]Drug
90mg sc bid for 12 weeks

Study groups in NCT00232908
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: ARV regimen; Drug: enfuvirtide [Fuzeon]

What is being measured

The primary outcome is the main question the study is designed to answer.

QoL (MOS-HIV)\n
Measured: Baseline and Week 12

Secondary outcomes (2)

Change from baseline in HIV-RNA
Measured: Week 12
Change from baseline in CD4 count
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004Oct 2005

First posted5 Oct 2005 (estimated)
Study startJun 2004
Primary completionOct 2005
Study completionOct 2005

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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00232908
Sponsor's protocol ID: ML18018
Status last verified: Nov 2016
First submitted: 4 Oct 2005
Last updated: 2 Nov 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection
ClinicalTrials.gov ID: NCT00232908
Acronym / sponsor ID: ML18018
Conditions: HIV Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 5 Oct 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: ARV regimen, Drug: enfuvirtide [Fuzeon]

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

adults or adolescents at least 16 years of age;
HIV-1 infection;
clinically stable, treatment-experienced;
evidence of HIV-1 replication despite ongoing antiretroviral therapy;
CD4 + count greater than 50 cells/mm3.

Key exclusion criteria (3 listed)

previous use of Fuzeon and/or T-1249;
active, untreated opportunistic infection;
inability to self-inject, unless a reliable caregiver is available to inject.

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
ARV regimenAs prescribed	Drug	1
enfuvirtide [Fuzeon]90mg sc bid for 12 weeks	Drug	1

Primary outcome

QoL (MOS-HIV)\n
Time frame: Baseline and Week 12

2 secondary outcomes

Change from baseline in HIV-RNA
Time frame: Week 12
Change from baseline in CD4 count
Time frame: Week 12

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 2 Nov 2016.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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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

106 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 ARV regimen and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 106 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 5 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 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?

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?

QoL (MOS-HIV)\n (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00232908.

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 2 Nov 2016.