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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Enfuvirtide

• Registration Number: NCT02582983
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Status Verified: 2016-05
• Results First Submitted: 2016-05-25
• Results First Submitted QC: 2016-05-25
• Last Update Submitted: 2016-05-25
• Results First Posted: 2016-07-06
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enfuvirtide	Enfuvirtide	Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Premature Withdrawal Due to Adverse Events	Up to 96 weeks
Number of Participants With Serious Adverse Events (SAEs)	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.