HIV InfectionPhase 4NCT00100984
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
A Phase 4 study testing FUZEON [enfuvirtide] in people with HIV Infection, run by Hoffmann-La Roche at 20 sites in United States.
Trial summary
The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- FUZEON [enfuvirtide]
- How many people
- 8 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 Jul 2004to 16 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD4 cell count greater than 50 cells/mm^3
- HIV-1 RNA viral load greater than or equal to 5000 copies/mL
- Patients must be HIV treatment experienced
- Patients diagnosed with HIV-1 infection
Who cannot join
- Female patients must not be able to have children or must be under effective contraceptives
- Female patients who are pregnant
- Have taken enfuvirtide and/or T-1249 before
- Have serious kidney problems
- Alcohol and/or drug abuse
- Have had an organ transplant
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Atlanta, Georgia, 30308
Study site
Baltimore, Maryland, 21201
Study site
Boston, Massachusetts, 02215-3318
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60657
Study site
Dallas, Texas, 75246
Study site
Hobson City, Alabama, 36201
Study site
Houston, Texas, 77004
Study site
Huntersville, North Carolina, 28078
Study site
Jackson, Mississippi, 39216-4505
Study site
Los Angeles, California, 90033
Study site
Los Angeles, California, 90036
Study site
Macon, Georgia, 31201
Study site
New York, New York, 10011
Study site
New York, New York, 10016
Study site
Newark, New Jersey, 07103
Study site
Orlando, Florida, 32803
Study site
St Louis, Missouri, 63139
Study site
Washington D.C., District of Columbia, 20007
Study site
Washington D.C., District of Columbia, 20009
About this study
The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.
- Conditions
- HIV Infection
- Being tested
- FUZEON [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.
FUZEON [enfuvirtide]Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
- Study start21 Jul 2004
- Primary completion16 Jul 2005
- Study completion16 Jul 2005
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100984
- Sponsor's protocol ID
- ML18021
- Status last verified
- Dec 2005
- First submitted
- 7 Jan 2005
- Last updated
- 20 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
- ClinicalTrials.gov ID
- NCT00100984
- Acronym / sponsor ID
- ML18021
- Conditions
- HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2004 (actual)
- Primary completion
- 16 Jul 2005 (actual)
- Study completion
- 16 Jul 2005 (actual)
- First posted
- 10 Jan 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 main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CD4 cell count greater than 50 cells/mm^3
- HIV-1 RNA viral load greater than or equal to 5000 copies/mL
- Patients must be HIV treatment experienced
- Patients diagnosed with HIV-1 infection
Key exclusion criteria (6 listed)
- Female patients must not be able to have children or must be under effective contraceptives
- Female patients who are pregnant
- Have taken enfuvirtide and/or T-1249 before
- Have serious kidney problems
- Alcohol and/or drug abuse
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 |
|---|---|---|
| FUZEON [enfuvirtide] | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 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 FUZEON [enfuvirtide] in people with HIV Infection, run by Hoffmann-La Roche at 20 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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.
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 20 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.