Clinical trial NCT00488059: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
Official title: A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2007-06-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>=18 years of age
* HIV-1 infection
* Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive
* GSS \>= 3 ; nucleosides excluded

Exclusion Criteria:

* Adverse clinical or laboratory experience \>ACTG Grade 4
* Untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen
* Malignancy requiring chemotherapy or radiotherapy

Primary outcomes:
measure: Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL
timeFrame: Between Week I-4 and Week I-12 of Phase I of the study
measure: Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16
timeFrame: Week II-16
Secondary outcomes:
measure: Virologic Response Over Time in Phase I of the Study
timeFrame: Weeks 4, 8 & 12
measure: HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study
timeFrame: Baseline and Weeks 4, 8, 12 & LOCF
measure: Virologic Response Over Time in Phase II of the Study
timeFrame: Weeks II-4, 8, 12 & 16
measure: CD4+ Lymphocyte Count Change From Baseline
timeFrame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF
measure: Percentage of Patients With Ongoing Injection Site Reactions (ISRs)
timeFrame: Phase I and II
Other outcomes:
Locations:
city: Hobson City
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
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: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Stanford
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Palm Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port St Lucie
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: Briarcliff Manor
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Allentown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Reading
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: Annandale
country: United States
state: Virginia
city: Ponce
country: Puerto Rico
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: