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

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Optimized Background ARVs; Drug: enfuvirtide [Fuzeon]

• Registration Number: NCT00089492
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-08-05
• Study First Submitted QC: 2004-08-05
• Study First Posted: 2004-08-06
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	enfuvirtide [Fuzeon]	-
2	enfuvirtide [Fuzeon]	-
1	Optimized Background ARVs	-
2	Optimized Background ARVs	-

Primary Outcome Measures

Name	Time	Method
Viral load.\n\n	Week 48

Secondary Outcome Measures

Name	Time	Method
CD4 lymphocyte count.	Week 48
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n	Throughout study