HIV InfectionsPhase 2NCT00089492
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
A Phase 2 study testing Optimized Background ARVs and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 27 sites in 3 countries.
Trial summary
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. 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?
- Optimized Background ARVs and enfuvirtide [Fuzeon]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 27 sitesin 3 countries
- Study dates
- Jul 2004to Jun 2006
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-1 infected adults or adolescents >=16 years of age;
- HIV-1 RNA >=5000 copies/mL;
- prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).
Who cannot join
- history of prior use of Fuzeon or T-1249;
- female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
- current severe illness;
- currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States21 sites
Study site
Albany, New York, 12208
Study site
Allentown, Pennsylvania, 18102-7017
Study site
Atlanta, Georgia, 30308
Study site
Austin, Texas, 78705
Study site
Boston, Massachusetts, 02118
Study site
Bradenton, Florida, 34209
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202-2689
Study site
Fountain Valley, California, 92708
Study site
Hobson City, Alabama, 36201
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90022
Study site
Los Angeles, California, 90048
Study site
Miami, Florida, 33136
Study site
New Orleans, Louisiana, 70112
Study site
North Miami Beach, Florida, 33169
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19102
Study site
Philadelphia, Pennsylvania, 19107
Study site
Sarasota, Florida, 34239
Study site
Union, New Jersey, 07083
Canada3 sites
Study site
Montreal, Quebec, H2X 2P4
Study site
Montreal, Quebec, H3G 1A4
Study site
Toronto, Ontario, M5G 2C4
Puerto Rico3 sites
Study site
Ponce, 00732
Study site
San Juan, 00921-3201
Study site
San Juan, 00935
About this study
Official title: A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- HIV Infections
- Being tested
- Optimized Background ARVs, 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.
Optimized Background ARVsDrug
As prescribed
enfuvirtide [Fuzeon]Drug
180mg sc once daily for 48 weeks
enfuvirtide [Fuzeon]Drug
90mg sc bid for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Optimized Background ARVs; Drug: enfuvirtide [Fuzeon] |
| 2 | Active comparator | Not described Receives: Drug: Optimized Background ARVs; Drug: enfuvirtide [Fuzeon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load.\n\n
Measured: Week 48
Secondary outcomes (2)
CD4 lymphocyte count.
Measured: Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
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 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionJun 2006
- Study completionJun 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT00089492
- Sponsor's protocol ID
- NV17658
- Status last verified
- Nov 2016
- First submitted
- 5 Aug 2004
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73.
PubMed 18474492
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
- A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
- ClinicalTrials.gov ID
- NCT00089492
- Acronym / sponsor ID
- NV17658
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Study start
- Jul 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 6 Aug 2004 (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 study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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: Optimized Background ARVs, Drug: enfuvirtide [Fuzeon] |
| 2 | Active comparator | Drug: Optimized Background ARVs, 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 (3 listed)
- HIV-1 infected adults or adolescents >=16 years of age;
- HIV-1 RNA >=5000 copies/mL;
- prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).
Key exclusion criteria (4 listed)
- history of prior use of Fuzeon or T-1249;
- female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
- current severe illness;
- currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
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 |
|---|---|---|
| Optimized Background ARVsAs prescribed | Drug | 1, 2 |
| enfuvirtide [Fuzeon]180mg sc once daily for 48 weeks | Drug | 1 |
| enfuvirtide [Fuzeon]90mg sc bid for 48 weeks | Drug | 2 |
Primary outcome
Viral load.\n\n
Time frame: Week 48
2 secondary outcomes
CD4 lymphocyte count.
Time frame: Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
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 2 Nov 2016.
- Derived from this study: PubMed 18474492Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73.
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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
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Optimized Background ARVs and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 27 sites in 3 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 3 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 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 27 sites in United States, Canada, 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 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?
Viral load.\n\n (time frame: Week 48). 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 NCT00089492, 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 2 Nov 2016.