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

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: ARV regimen; Drug: enfuvirtide [Fuzeon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232908

ML18018

Details and patient eligibility

About

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.

Enrollment: 361 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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361 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ARV regimen

Drug: enfuvirtide [Fuzeon]