A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

HIV Infections Clinical Trial

Official title:

A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089492
• Other study ID #: NV17658
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2004
• Last updated: November 1, 2016
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• HIV-1 infected adults or adolescents >=16 years of age;

• HIV-1 RNA >=5000 copies/mL;

• prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria:

• history of prior use of Fuzeon or T-1249;

• female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;

• current severe illness;

• currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Optimized Background ARVs
As prescribed
• enfuvirtide [Fuzeon]
180mg sc once daily for 48 weeks
• enfuvirtide [Fuzeon]
90mg sc bid for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load.\n\n		Week 48	No
Secondary	CD4 lymphocyte count.		Week 48	No
Secondary	AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n		Throughout study	No