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

NCT ID: NCT00488059

Last Updated: 2011-07-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase I

Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).

Group Type EXPERIMENTAL

enfuvirtide [Fuzeon]

Intervention Type DRUG

90 mg SC twice daily

Optimized background ARV

Intervention Type DRUG

As prescribed

Integrase inhibitor

Intervention Type DRUG

As prescribed

Phase II

In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of

(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.

Group Type EXPERIMENTAL

Optimized background ARV

Intervention Type DRUG

As prescribed

Integrase inhibitor

Intervention Type DRUG

As prescribed

enfuvirtide [Fuzeon]

Intervention Type DRUG

180 mg SC once daily

Interventions

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enfuvirtide [Fuzeon]

90 mg SC twice daily

Intervention Type DRUG

Optimized background ARV

As prescribed

Intervention Type DRUG

Integrase inhibitor

As prescribed

Intervention Type DRUG

enfuvirtide [Fuzeon]

180 mg SC once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trimeris

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Hoffmann-La Roche

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hobson City, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Modesto, California, United States

Site Status

Stanford, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Fort Myers, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Miami Beach, Florida, United States

Site Status

North Palm Beach, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Plantation, Florida, United States

Site Status

Port Saint Lucie, Florida, United States

Site Status

Safety Harbor, Florida, United States

Site Status

South Miami, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Atlanta, Georgia, United States

Site Status

Macon, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Silver Spring, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Kansas City, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Newark, New Jersey, United States

Site Status

Briarcliff Manor, New York, United States

Site Status

New York, New York, United States

Site Status

Rochester, New York, United States

Site Status

The Bronx, New York, United States

Site Status

Allentown, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Reading, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

Fort Worth, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Annandale, Virginia, United States

Site Status

Ponce, , Puerto Rico

Site Status

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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ML20837

Identifier Type: -

Identifier Source: org_study_id

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