Clinical Trials

MainTitle

A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT02582983

First received: October 8, 2015
Last updated: May 25, 2016
Last Verified: May 2016
History of Changes
Purpose

Purpose

This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.

Condition Intervention Phase
HIV Infections

Drug : Enfuvirtide
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) ]
    A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.
  • Number of Participants With Premature Withdrawal Due to Adverse Events [ Time Frame: Up to 96 weeks ]

Enrollment: 23
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Enfuvirtide
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
Drug: Enfuvirtide

All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.

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:

  • Individuals at least 16 years of age infected with HIV-1
  • CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
  • Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens


Exclusion Criteria:
  • Evidence of ongoing alcohol and/or drug or substance abuse
  • Prior non-adherence to antiretroviral treatment regimens
  • Evidence of active, untreated opportunistic infection, intercurrent illness, drug
toxicity or any other condition.

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: NCT02582983

Locations

Thailand
Bangkok, Thailand, 10110
Bangkok, Thailand, 10330
Bangkok, Thailand, 10700
Chiang Mai, Thailand, 50200
Nonthaburi, Thailand, 11000

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: NCT02582983   History of Changes  
Other Study ID Numbers: ML17819  
Study First Received: October 8, 2015  
Last Updated: May 25, 2016  

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Enfuvirtide

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.