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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02569502
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 1, 2005
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

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 Names:
  • Fuzeon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants who discontinue enfuvirtide due to adverse events\n [Up to 102 weeks]

    2. Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections [Up to 102 weeks]

    3. Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events [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 [Up to 28 days after discontinuation of enfuvirtide]

    2. Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR [Up to 102 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sofia Bulgaria 1431

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Chair: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02569502
    Other Study ID Numbers:
    • ML18634
    First Posted:
    Oct 6, 2015
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Enfuvirtide

    Study Results

    No Results Posted as of Nov 2, 2016