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

Hoffmann-La Roche361 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

361

Conditions

HIV Infections

Interventions

ARV regimenDRUG

As prescribed

enfuvirtide [Fuzeon]DRUG

90mg sc bid for 12 weeks

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (106)

Outcomes

Primary Outcomes

QoL (MOS-HIV)\n

Time frame: Baseline and Week 12

Secondary Outcomes

Change from baseline in HIV-RNA

Time frame: Week 12

Change from baseline in CD4 count

Time frame: Week 12

Data from ClinicalTrials.gov

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Unnamed facility

Phoenix, Arizona, United States

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Bakersfield, California, United States

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Berkeley, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

...and 96 more locations