QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 8/3/2016 |
| Start Date: | June 2004 |
| End Date: | October 2005 |
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
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.
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.
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.
We found this trial at
82
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