BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2006 |
| End Date: | September 2007 |
An Open-label Study to Evaluate the Effect on Viral Load of a New Investigational Protease Inhibitor With Fuzeon Plus a Background Antiretroviral Regimen in Triple-class Treatment-experienced Patients With HIV-1 Infection
This single arm study will evaluate the efficacy, safety and tolerability of a new
investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc
bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new
investigational PI will be administered according to the procedures of the early access
program in which the patient is enrolled. The anticipated time on study treatment is 3-12
months, and the target sample size is 100-500 individuals.
investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc
bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new
investigational PI will be administered according to the procedures of the early access
program in which the patient is enrolled. The anticipated time on study treatment is 3-12
months, and the target sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients, >=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion Criteria:
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
We found this trial at
29
sites
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