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

NCT02569502 | Completed Phase 4

• 1 other identifier: ML18634
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• Percentage of participants who discontinue enfuvirtide due to adverse events\n

  Up to 102 weeks

• Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections

  Up to 102 weeks

• Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events

  Up to 102 weeks

Secondary Outcomes (2)

• 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

• Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR

  Up to 102 weeks

Study Arms (1)

Enfuvirtide

EXPERIMENTAL

Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections

Drug: enfuvirtide

Interventions

enfuvirtide DRUG

Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.

Also known as: Fuzeon

Enfuvirtide

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding;
• Patients unable to self-inject;
• Active, untreated opportunistic infection.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Sofia, 1431, Bulgaria

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; HIV Envelope Protein gp41; Viral Fusion Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; HIV Antigens; Antigens, Viral; Viral Proteins; env Gene Products, Human Immunodeficiency Virus; Gene Products, env; Retroviridae Proteins; Human Immunodeficiency Virus Proteins; Viral Envelope Proteins; Viral Structural Proteins; Antigens; Biological Factors

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: April 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BU (1)