HIV InfectionsPhase 4NCT00326963
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
A Phase 4 study testing Background ARVs, PI and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 38 sites in 2 countries.
Trial summary
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. 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?
- Background ARVs, PI and enfuvirtide [Fuzeon]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Mar 2006to May 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adult patients, >=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Who cannot join
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States32 sites
Study site
Albany, New York, 12208
Study site
Annandale, Virginia, 22003
Study site
Bakersfield, California, 93301
Study site
Baltimore, Maryland, 21201
Study site
Beverly Hills, California, 90210
Study site
Dallas, Texas, 75246
Study site
Decatur, Georgia, 30033
Study site
Fort Lauderdale, Florida, 33334
Study site
Fort Worth, Texas, 76104
Study site
Hampton, Virginia, 23666
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77098
Study site
Huntersville, North Carolina, 28078
Study site
Los Angeles, California, 90027
Study site
Los Angeles, California, 90028
Study site
Los Angeles, California, 90036
Study site
Macon, Georgia, 31201
Study site
New York, New York, 10003
Study site
New York, New York, 10032
Study site
Newark, New Jersey, 07102
Study site
Norwalk, Connecticut, 06851
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85006
Study site
Port Saint Lucie, Florida, 34952
Study site
Portland, Oregon, 97209-2534
Study site
San Francisco, California, 94114
Study site
Somers Point, New Jersey, 08244
Study site
St Louis, Missouri, 63139
Study site
Stanford, California, 94305
Study site
Tarzana, California, 91356
Study site
Washington D.C., District of Columbia, 20009
Australia6 sites
Study site
Brisbane, 4000
Study site
Carlton, 3053
Study site
Liverpool, 2170
Study site
Melbourne, 3181
Study site
South Yarra, 3141
Study site
Sydney, 2010
About this study
Official title: A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
- Conditions
- HIV Infections
- Being tested
- Background ARVs, PI, 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.
Background ARVsDrug
As prescribed
PIDrug
As prescribed
enfuvirtide [Fuzeon]Drug
90mg sc bid
| Study group | Role | What they receive |
|---|---|---|
| Enfuvirtide+PI+ARV's | Experimental | Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID). Receives: Drug: Background ARVs; Drug: PI; Drug: enfuvirtide [Fuzeon] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.
Measured: Week 24
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.
Measured: Week 24
Secondary outcomes (15)
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.
Measured: Week 4 and 12
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.
Measured: Week 4 and 12
Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.
Measured: Weeks 4, 12, and 24
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.
Measured: Weeks 4, 12, and 24
Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) - (plasma HIV-1 RNA count at baseline).
Measured: Baseline (Day 1), Weeks 4, 12, and 24
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.
Measured: Up to Week 28
Change From Baseline in CD4+ Lymphocyte Count
Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) - (CD4+ count at baseline).
Measured: Baseline (Day 1), Weeks 4, 12, and 24
Number of Participants Meeting Virologic Failure Criteria
The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Measured: Weeks 12 and 24
Percentage of Participants Meeting Virologic Failure Criteria
The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.
Measured: Weeks 12 and 24
Number of Participants Adhering to Enfuvirtide (ENF)
Adherence to ENF treatment regimen was calculated using the participant's response to the query on the "Participant Adherence Questionnaire case report form (CRF)" about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.
Measured: Weeks 4, 12, and 24
Percentage of Participants Adhering to ENF
Adherence to ENF treatment regimen was calculated using the participant's response to the query on the "Participant Adherence Questionnaire case report form (CRF)" about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.
Measured: Weeks 4, 12, and 24
Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.
Measured: Week 1 to Week 24
Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.
Measured: Week 1 to Week 24
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.
Measured: Week 24
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 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
- NCT00326963
- Sponsor's protocol ID
- ML19712
- Status last verified
- Jul 2016
- First submitted
- 16 May 2006
- Last updated
- 16 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study Evaluating the Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients
- ClinicalTrials.gov ID
- NCT00326963
- Acronym / sponsor ID
- ML19712
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Study start
- Mar 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 17 May 2006 (estimated)
- Results
- Posted 16 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enfuvirtide+PI+ARV's | Experimental | Drug: Background ARVs, Drug: PI, Drug: enfuvirtide [Fuzeon]Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, >=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Key exclusion criteria (3 listed)
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
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 |
|---|---|---|
| Background ARVsAs prescribed | Drug | Enfuvirtide+PI+ARV's |
| PIAs prescribed | Drug | Enfuvirtide+PI+ARV's |
| enfuvirtide [Fuzeon]90mg sc bid | Drug | Enfuvirtide+PI+ARV's |
Primary outcome
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Time frame: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Time frame: Week 24
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.
15 secondary outcomes
Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Time frame: Week 4 and 12
Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
Time frame: Week 4 and 12
Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Time frame: Weeks 4, 12, and 24
Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
Time frame: Weeks 4, 12, and 24
Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
Time frame: Baseline (Day 1), Weeks 4, 12, and 24
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
Time frame: Up to Week 28
Change From Baseline in CD4+ Lymphocyte Count
Time frame: Baseline (Day 1), Weeks 4, 12, and 24
Number of Participants Meeting Virologic Failure Criteria
Time frame: Weeks 12 and 24
Percentage of Participants Meeting Virologic Failure Criteria
Time frame: Weeks 12 and 24
Number of Participants Adhering to Enfuvirtide (ENF)
Time frame: Weeks 4, 12, and 24
Percentage of Participants Adhering to ENF
Time frame: Weeks 4, 12, and 24
Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Time frame: Week 1 to Week 24
Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
Time frame: Week 1 to Week 24
Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
Time frame: Week 24
Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Background ARVs, PI and enfuvirtide [Fuzeon] in people with HIV Infections, run by Hoffmann-La Roche at 38 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 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL (time frame: Week 24). The study lists 2 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 16 Aug 2016.