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

HIV Infections Clinical Trial

Official title:

Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569502
• Other study ID #: ML18634
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: November 1, 2016
• Start date: April 2005
• Est. completion date: October 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who discontinue enfuvirtide due to adverse events\n		Up to 102 weeks	No
Primary	Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections		Up to 102 weeks	No
Primary	Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events		Up to 102 weeks	No
Secondary	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	No
Secondary	Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR		Up to 102 weeks	No