Clinical trial NCT00326963: BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2006-05-17
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* females who are pregnant or breast-feeding;
* evidence of active, untreated opportunistic infection;
* malignancy requiring chemotherapy or radiotherapy.

Primary outcomes:
measure: Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
timeFrame: Week 24
measure: Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL
timeFrame: Week 4 and 12
measure: Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL
timeFrame: Week 4 and 12
measure: Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL
timeFrame: Weeks 4, 12, and 24
measure: Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load
timeFrame: Baseline (Day 1), Weeks 4, 12, and 24
measure: Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: Up to Week 28
measure: Change From Baseline in CD4+ Lymphocyte Count
timeFrame: Baseline (Day 1), Weeks 4, 12, and 24
measure: Number of Participants Meeting Virologic Failure Criteria
timeFrame: Weeks 12 and 24
measure: Percentage of Participants Meeting Virologic Failure Criteria
timeFrame: Weeks 12 and 24
measure: Number of Participants Adhering to Enfuvirtide (ENF)
timeFrame: Weeks 4, 12, and 24
measure: Percentage of Participants Adhering to ENF
timeFrame: Weeks 4, 12, and 24
measure: Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
timeFrame: Week 1 to Week 24
measure: Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event
timeFrame: Week 1 to Week 24
measure: Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.
timeFrame: Week 24
measure: Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Norwalk
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Port St Lucie
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: St Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Brisbane
country: Australia
city: Carlton
country: Australia
city: Liverpool
country: Australia
city: Melbourne
country: Australia
city: South Yarra
country: Australia
city: Sydney
country: Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: