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HIV InfectionsPhase 4NCT00337701

BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

A Phase 4 study testing enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 44 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

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
enfuvirtide [Fuzeon]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
44 sitesin 2 countries
Study dates
Jun 2006to Jan 2007
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

  • adult patients >=16 years of age;
  • current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
  • naive to use of the B2000 device;
  • positive test results for human immunodeficiency virus infection.

Who cannot join

  • patients naive to Fuzeon;
  • inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
  • evidence of active, untreated, opportunistic infections.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States42 sites

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Berkley, Michigan, 48072-1550

  • Study site

    Birmingham, Alabama, 35294-2050

  • Study site

    Boise, Idaho, 83704

  • Study site

    Boston, Massachusetts, 02215-3318

  • Study site

    Chicago, Illinois, 60657

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80220

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Galveston, Texas, 77555

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Hayward, California, 94545

  • Study site

    Houston, Texas, 77027

  • Study site

    Houston, Texas, 77098

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90036

  • Study site

    New York, New York, 10011

  • Study site

    New York, New York, 10016

  • Study site

    North Miami Beach, Florida, 33169

  • Study site

    Orlando, Florida, 32803

  • Study site

    Palm Springs, California, 92262

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Plantation, Florida, 33317

  • Study site

    Port Saint Lucie, Florida, 34952

  • Study site

    Portland, Oregon, 97209-2534

  • Study site

    Rochester, New York, 14604

  • Study site

    San Francisco, California, 94115

  • Study site

    Santa Clara, California, 95051

  • Study site

    Silver Spring, Maryland, 20910

  • Study site

    Somers Point, New Jersey, 08244

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63139

  • Study site

    Tampa, Florida, 33614

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Study site

    Ponce, 00717-1563

  • Study site

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Conditions
HIV Infections
Being tested
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.

  • enfuvirtide [Fuzeon]Drug

    90mg sc bid by Biojector 2000 NFID for 8 weeks

  • enfuvirtide [Fuzeon]Drug

    90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.

Study groups in NCT00337701
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: enfuvirtide [Fuzeon]
2ExperimentalNot described
Receives: Drug: enfuvirtide [Fuzeon]

What is being measured

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

  1. Composite endpoint (pain, induration, nodules/cysts)

    Measured: Throughout study

Secondary outcomes (1)

  1. AEs and ISRs

    Measured: Throughout study

Timeline

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

  1. First posted16 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

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
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00337701
Sponsor's protocol ID
ML19849
Status last verified
Nov 2015
First submitted
15 Jun 2006
Last updated
3 Nov 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 44 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: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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?

Composite endpoint (pain, induration, nodules/cysts) (time frame: Throughout study). 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 NCT00337701.

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 3 Nov 2015.

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