BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326963
• Other study ID #: ML19712
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2006
• Last updated: November 2, 2015
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Background ARVs
As prescribed
• PI
As prescribed
• enfuvirtide [Fuzeon]
90mg sc bid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with plasma HIV-1 RNA <50 copies/mL		Week 24	No
Secondary	Plasma HIV-1 RNA <50 copies/mL		Weeks 4 and 12	No
Secondary	Plasma HIV-1 RNA <400 copies/mL		Weeks 4, 12 and 24	No
Secondary	Change from baseline in plasma RNA and CD4		Weeks 4, 12 and 24	No
Secondary	Adherence, ISRs, premature discontinuations, SAEs		Throughout study	No