BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

NCT00326963 | Completed Phase 4 Results

• 1 other identifier: ML19712
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 38

Brief Summary

This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL

  Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.

  Week 24

• Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL

  Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results \<50 copies/mL is reported.

  Week 24

Secondary Outcomes (15)

• Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL

  Week 4 and 12

• Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL

  Week 4 and 12

• Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL

  Weeks 4, 12, and 24

• Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL

  Weeks 4, 12, and 24

• Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load

  Baseline (Day 1), Weeks 4, 12, and 24

Study Arms (1)

Enfuvirtide+PI+ARV's

EXPERIMENTAL

Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).

Drug: Background ARVs; Drug: PI; Drug: enfuvirtide [Fuzeon]

Interventions

Background ARVs DRUG

As prescribed

Enfuvirtide+PI+ARV's

PI DRUG

As prescribed

Enfuvirtide+PI+ARV's

enfuvirtide [Fuzeon] DRUG

90mg sc bid

Enfuvirtide+PI+ARV's

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;
• seropositive for HIV-1;
• enrolled in an early access program for a new investigational PI;
• naive to Fuzeon, and the investigational PI;
• treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).

You may not qualify if:

• females who are pregnant or breast-feeding;
• evidence of active, untreated opportunistic infection;
• malignancy requiring chemotherapy or radiotherapy.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Trimeris: collaborator

Study Sites (38)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

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Bakersfield, California, 93301, United States

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Beverly Hills, California, 90210, United States

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Los Angeles, California, 90027, United States

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Los Angeles, California, 90028, United States

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Los Angeles, California, 90036, United States

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San Francisco, California, 94114, United States

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Stanford, California, 94305, United States

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Tarzana, California, 91356, United States

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Norwalk, Connecticut, 06851, United States

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

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Fort Lauderdale, Florida, 33334, United States

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Orlando, Florida, 32803, United States

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Port Saint Lucie, Florida, 34952, United States

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Decatur, Georgia, 30033, United States

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Macon, Georgia, 31201, United States

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Baltimore, Maryland, 21201, 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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Somers Point, New Jersey, 08244, United States

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Albany, New York, 12208, United States

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New York, New York, 10003, United States

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New York, New York, 10032, United States

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Huntersville, North Carolina, 28078, United States

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Portland, Oregon, 97209-2534, United States

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Philadelphia, Pennsylvania, 19107, 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, 77004, United States

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Houston, Texas, 77098, United States

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Annandale, Virginia, 22003, United States

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Hampton, Virginia, 23666, United States

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Brisbane, 4000, Australia

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Carlton, 3053, Australia

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Liverpool, 2170, Australia

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Melbourne, 3181, Australia

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South Yarra, 3141, Australia

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Sydney, 2010, Australia

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MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

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

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 17, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: August 16, 2016
• Results First Posted: August 16, 2016

Record last verified: 2016-07

Locations

AU (6); US (32)