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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: ARV regimen; Drug: enfuvirtide [Fuzeon]

• Registration Number: NCT00232908
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. 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: 2004-06
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

• adults or adolescents at least 16 years of age;
• HIV-1 infection;
• clinically stable, treatment-experienced;
• evidence of HIV-1 replication despite ongoing antiretroviral therapy;
• CD4 + count greater than 50 cells/mm3.

Exclusion Criteria

• previous use of Fuzeon and/or T-1249;
• active, untreated opportunistic infection;
• inability to self-inject, unless a reliable caregiver is available to inject.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ARV regimen	-
1	enfuvirtide [Fuzeon]	-

Primary Outcome Measures

Name	Time	Method
QoL (MOS-HIV)\n	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HIV-RNA	Week 12
Change from baseline in CD4 count	Week 12