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OpenTrials
Completed

NCT Number: NCT02569502

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sofia, 1431, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enfuvirtide

Drug

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

Other names: Fuzeon

Primary outcomes

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

    Time frame: Up to 102 weeks

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

    Time frame: Up to 102 weeks

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

    Time frame: Up to 102 weeks

Secondary outcomes

  1. 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

    Time frame: Up to 28 days after discontinuation of enfuvirtide

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

    Time frame: Up to 102 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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