HIV InfectionsPhase 4NCT02569502
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
A Phase 4 study testing enfuvirtide in people with HIV Infections, run by Hoffmann-La Roche at 1 site in Bulgaria.
Trial summary
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBulgaria
- Study dates
- Apr 2005to Oct 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 or adolescent patients greater than (>)16 years of age
- HIV-1 infection
- CD4 count less than (<)350/cubic millimeters (mm^3)
- HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
- Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Who cannot join
- Women who are pregnant or breastfeeding;
- Patients unable to self-inject;
- Active, untreated opportunistic infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
- Conditions
- HIV Infections
- Being tested
- enfuvirtide
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfuvirtideDrug
Also called Fuzeon
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Enfuvirtide | Experimental | Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections Receives: Drug: enfuvirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Measured: Up to 102 weeks
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Measured: Up to 102 weeks
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Measured: Up to 102 weeks
Secondary outcomes (2)
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Measured: Up to 28 days after discontinuation of enfuvirtide
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Measured: Up to 102 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startApr 2005
- Primary completionOct 2007
- Study completionOct 2007
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569502
- Sponsor's protocol ID
- ML18634
- Status last verified
- Nov 2016
- First submitted
- 5 Oct 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
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
- Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
- ClinicalTrials.gov ID
- NCT02569502
- Acronym / sponsor ID
- ML18634
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Oct 2015 (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 evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enfuvirtide | Experimental | Drug: enfuvirtideParticipants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections |
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)
- Adult or adolescent patients greater than (>)16 years of age
- HIV-1 infection
- CD4 count less than (<)350/cubic millimeters (mm^3)
- HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
- Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding;
- Patients unable 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 |
|---|---|---|
| enfuvirtideAlso: FuzeonParticipants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection. | Drug | Enfuvirtide |
Primary outcome
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Time frame: Up to 102 weeks
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Time frame: Up to 102 weeks
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Time frame: Up to 102 weeks
2 secondary outcomes
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Time frame: Up to 28 days after discontinuation of enfuvirtide
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Time frame: Up to 102 weeks
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.
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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 chair
Hoffmann-La Roche
1 site 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 in people with HIV Infections, run by Hoffmann-La Roche at 1 site in Bulgaria.
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 1 site in Bulgaria. 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?
Percentage of participants who discontinue enfuvirtide due to adverse events\n (time frame: Up to 102 weeks). The study lists 3 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 2 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.