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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02569502

Enrollment

Registered

2015-10-06

Start date

2005-04-30

Completion date

2007-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGenfuvirtide

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026