Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT02569502

First received: October 5, 2015
Last updated: November 1, 2016
Last Verified: November 2016
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : enfuvirtide
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures

  • Percentage of participants who discontinue enfuvirtide due to adverse events\n [ Time Frame: Up to 102 weeks ]
  • Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections [ Time Frame: Up to 102 weeks ]
  • Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events [ Time Frame: Up to 102 weeks ]
Secondary Outcome Measures:
  • 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 ]
  • Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR [ Time Frame: Up to 102 weeks ]

Enrollment: 6
Study Start Date: April 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02569502

Locations

Bulgaria
Sofia, Bulgaria, 1431

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair: Clinical Trials Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT02569502   History of Changes  
Other Study ID Numbers: ML18634  
Study First Received: October 5, 2015  
Last Updated: November 1, 2016  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Enfuvirtide

ClinicalTrials.gov processed this data on December 13, 2019
This information is provided by ClinicalTrials.gov.