HIV InfectionsPhase 4NCT00233883
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
A Phase 4 study testing enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. 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]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2005to Jul 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients, >=18 years of age with HIV-1 infection;
- previously treated with antiretroviral agents.
Who cannot join
- prior use of Fuzeon or T-1249;
- inability to self-inject;
- active, untreated opportunistic infection.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Annandale, Virginia, 22003
Study site
Atlanta, Georgia, 30309
Study site
Boston, Massachusetts, 02215-3318
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60657
Study site
Dallas, Texas, 75246
Study site
Detroit, Michigan, 48201
Study site
Fort Lauderdale, Florida, 33334
Study site
Houston, Texas, 77004
Study site
Long Beach, California, 90813
Study site
Los Angeles, California, 90022
Study site
Los Angeles, California, 90036
Study site
Los Angeles, California, 90210
Study site
South Miami, Florida, 33143
Study site
St Louis, Missouri, 63139
Study site
Washington D.C., District of Columbia, 20009
Study site
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 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 4 weeks
enfuvirtide [Fuzeon]Drug
90mg sc bid by 27G1/2" needle/syringe for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: enfuvirtide [Fuzeon] |
| 2 | Active comparator | Not described Receives: Drug: enfuvirtide [Fuzeon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint (pain, induration, nodules/cysts).
Measured: Throughout study
Secondary outcomes (2)
Steady state C trough
Measured: Weekly
Signs and symptoms associated with Fuzeon injections
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 posted6 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233883
- Sponsor's protocol ID
- ML18596
- Status last verified
- Nov 2015
- First submitted
- 4 Oct 2005
- Last updated
- 3 Nov 2015
- Results posted
- No
Publications
Gottlieb M, Thommes JA; WAND Study Team. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13(5):723-7.
PubMed 18771056
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults
- ClinicalTrials.gov ID
- NCT00233883
- Acronym / sponsor ID
- ML18596
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Study start
- Aug 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 6 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.
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: enfuvirtide [Fuzeon] |
| 2 | Active comparator | Drug: enfuvirtide [Fuzeon] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female patients, >=18 years of age with HIV-1 infection;
- previously treated with antiretroviral agents.
Key exclusion criteria (3 listed)
- prior use of Fuzeon or T-1249;
- inability to self-inject;
- active, untreated opportunistic infection.
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 by Biojector 2000 NFID for 4 weeks | Drug | 1 |
| enfuvirtide [Fuzeon]90mg sc bid by 27G1/2" needle/syringe for 4 weeks | Drug | 2 |
Primary outcome
Composite endpoint (pain, induration, nodules/cysts).
Time frame: Throughout study
2 secondary outcomes
Steady state C trough
Time frame: Weekly
Signs and symptoms associated with Fuzeon injections
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 3 Nov 2015.
- Derived from this study: PubMed 18771056Gottlieb M, Thommes JA; WAND Study Team. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13(5):723-7.
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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
17 sites in 1 country: see every site and its status.
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 17 sites in United States.
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 2 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 17 sites in United States. 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 NCT00233883, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.