A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

HIV Infections Clinical Trial

— AMICI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00488059
• Other study ID #: ML20837
• Status: Terminated
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: July 18, 2011
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• enfuvirtide [Fuzeon]
90 mg SC twice daily
• Optimized background ARV
As prescribed
• Integrase inhibitor
As prescribed
• enfuvirtide [Fuzeon]
180 mg SC once daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load = 50 Copies/mL	Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment = 50 copies/mL at the next visit (Week I-8 to Week II-16)	Between Week I-4 and Week I-12 of Phase I of the study	No
Primary	Number of Patients in Phase II of the Study With HIV-1 RNA = 50 Copies/mL at Week II-16		Week II-16	No
Secondary	Virologic Response Over Time in Phase I of the Study	The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.	Weeks 4, 8 & 12	No
Secondary	HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study	Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study	Baseline and Weeks 4, 8, 12 & LOCF	No
Secondary	Virologic Response Over Time in Phase II of the Study	The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.	Weeks II-4, 8, 12 & 16	No
Secondary	CD4+ Lymphocyte Count Change From Baseline	Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.; Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II - 12 and 16.	Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF	No
Secondary	Percentage of Patients With Ongoing Injection Site Reactions (ISRs)		Phase I and II	Yes

External Links

•   Clinical Study Report Synopsis