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

NCT00488059 | Terminated Phase 4 Results

• 1 other identifier: ML20837
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 43

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.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (2)

• 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

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

  Week II-16

Secondary Outcomes (5)

• Virologic Response Over Time in Phase I of the Study

  Weeks 4, 8 & 12

• HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study

  Baseline and Weeks 4, 8, 12 & LOCF

• Virologic Response Over Time in Phase II of the Study

  Weeks II-4, 8, 12 & 16

• CD4+ Lymphocyte Count Change From Baseline

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

• Percentage of Patients With Ongoing Injection Site Reactions (ISRs)

  Phase I and II

Study Arms (2)

Phase I

EXPERIMENTAL

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).

Drug: enfuvirtide [Fuzeon]; Drug: Optimized background ARV; Drug: Integrase inhibitor

Phase II

EXPERIMENTAL

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.

Drug: Optimized background ARV; Drug: Integrase inhibitor; Drug: enfuvirtide [Fuzeon]

Interventions

enfuvirtide [Fuzeon] DRUG

90 mg SC twice daily

Phase I

Optimized background ARV DRUG

As prescribed

Phase I; Phase II

Integrase inhibitor DRUG

As prescribed

Phase I; Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Trimeris: collaborator

Study Sites (43)

Unknown Facility

Hobson City, Alabama, 36201, United States

Location

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Phoenix, Arizona, 85006, United States

Location

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Los Angeles, California, 90027, United States

Location

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Los Angeles, California, 90028, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90069, United States

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Modesto, California, 95350, United States

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Stanford, California, 94305, United States

Location

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Washington D.C., District of Columbia, 20009, United States

Location

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Fort Lauderdale, Florida, 33307, United States

Location

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Fort Lauderdale, Florida, 33334, United States

Location

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Fort Myers, Florida, 39912, United States

Location

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Miami, Florida, 33133, United States

Location

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Miami Beach, Florida, 33139, United States

Location

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North Palm Beach, Florida, 33408, United States

Location

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Orlando, Florida, 32803, United States

Location

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Plantation, Florida, 33317, United States

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Port Saint Lucie, Florida, 34952, United States

Location

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Safety Harbor, Florida, 36495, United States

Location

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South Miami, Florida, 33143, United States

Location

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Tampa, Florida, 33614, United States

Location

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Atlanta, Georgia, 30309, United States

Location

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Atlanta, Georgia, 30318, United States

Location

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Macon, Georgia, 31201, United States

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Chicago, Illinois, 60657, United States

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Silver Spring, Maryland, 20910, United States

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Boston, Massachusetts, 02215-3318, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63139, United States

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Newark, New Jersey, 07102, United States

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Briarcliff Manor, New York, 10510, United States

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New York, New York, 10003, United States

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Rochester, New York, 14604, United States

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The Bronx, New York, 10467-2490, United States

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Allentown, Pennsylvania, 18102-7017, United States

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Philadelphia, Pennsylvania, 19107, United States

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Reading, Pennsylvania, 19601, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77098, United States

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Annandale, Virginia, 22003, United States

Location

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Ponce, 00717-1563, Puerto Rico

Location

Unknown Facility

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide; Integrase Inhibitors

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; HIV Envelope Protein gp41; Viral Fusion Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; HIV Antigens; Antigens, Viral; Viral Proteins; env Gene Products, Human Immunodeficiency Virus; Gene Products, env; Retroviridae Proteins; Human Immunodeficiency Virus Proteins; Viral Envelope Proteins; Viral Structural Proteins; Antigens; Biological Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 22, 2011
• Results First Posted: June 29, 2011

Record last verified: 2011-07

Locations

US (41); PR (2)