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

Phase 4TerminatedNCT00488059

Hoffmann-La Roche29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (43)

Unnamed facility

Hobson City, Alabama, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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)

Time frame: Between Week I-4 and Week I-12 of Phase I of the study

Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16

Time frame: Week II-16

Secondary Outcomes

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.

Time frame: Weeks 4, 8 & 12

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

Time frame: Baseline and Weeks 4, 8, 12 & LOCF

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.

Time frame: Weeks II-4, 8, 12 & 16

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.

Time frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF

Percentage of Patients With Ongoing Injection Site Reactions (ISRs)

Time frame: Phase I and II