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A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02569502
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: enfuvirtide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
Study Start Date : April 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arm Intervention/treatment
Experimental: Enfuvirtide
Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
Drug: enfuvirtide
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
Other Name: Fuzeon

Primary Outcome Measures :
  1. Percentage of participants who discontinue enfuvirtide due to adverse events\n [ Time Frame: Up to 102 weeks ]
  2. Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections [ Time Frame: Up to 102 weeks ]
  3. Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events [ Time Frame: Up to 102 weeks ]

Secondary Outcome Measures :
  1. Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug [ Time Frame: Up to 28 days after discontinuation of enfuvirtide ]
  2. Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR [ Time Frame: Up to 102 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult or adolescent patients greater than (>)16 years of age
  • HIV-1 infection
  • CD4 count less than (<)350/cubic millimeters (mm^3)
  • HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
  • Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding;
  • Patients unable to self-inject;
  • Active, untreated opportunistic infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02569502

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Sofia, Bulgaria, 1431
Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT02569502    
Other Study ID Numbers: ML18634
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Communicable Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents