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

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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)

361 participants in 1 patient group

1
Experimental group
Treatment:
Drug: ARV regimen
Drug: enfuvirtide [Fuzeon]

Trial contacts and locations

106

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Data sourced from clinicaltrials.gov

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