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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Enfuvirtide

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Fuzeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs)	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.	Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Number of Participants With Premature Withdrawal Due to Adverse Events		Up to 96 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: ML17819