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OpenTrials
Completed

NCT Number: NCT00232908

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cagaus, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARV regimen

Drug

As prescribed

enfuvirtide [Fuzeon]

Drug

90mg sc bid for 12 weeks

Primary outcomes

  1. QoL (MOS-HIV)\n

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change from baseline in HIV-RNA

    Time frame: Week 12

  2. Change from baseline in CD4 count

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 5, 2005
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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