Fuzeon Viral Decay Pilot Study

NCT ID: NCT00334022

Last Updated: 2012-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-01-31

Brief Summary

In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).

Conditions

HIV-1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Did not receive enfuvirtide

patients were randomized to either receive enfuviratide or not receive it

Group Type: PLACEBO_COMPARATOR

enfuvirtide

Intervention Type: DRUG

1ml BID

enfuvirtide

enfuvirtide 1ml BID

Group Type: ACTIVE_COMPARATOR

enfuvirtide

Intervention Type: DRUG

1ml BID

Interventions

enfuvirtide

1ml BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient must be HIV infected

2. Patient must be > 18 years old

3. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years

4. Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load

5. Patient must have a CD4 count above 400 cells/mm3 in last 3 months

6. Female patient must agree to use two methods of birth control or abstinence during the period of the study

7. Patient has to have signed full informed consent

Exclusion Criteria

1. Patient who would have difficulty participating in a trial due to non-adherence or substance abuse

2. Patient who have taken mono or dual antiretroviral therapy

3. Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen

4. Patient with any of the following abnormal laboratory test results in screening:

• Hemaglobin < 100 g/L
• Neutrophil count < 750 cells/uL
• Platelet count < 50,000 cells/L
• AST or ALT > 5X the upper limit of normal
• Creatinine > 250 umol/L

5. Patient with a malignancy

6. Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death

7. Patient with an active AIDS-defining illnesses in the past six months

8. Patients who are pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Canadian Immunodeficiency Research Collaborative

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Kovacs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Maple Leaf Medical Clinic

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Roche-FVD-1

Identifier Type: -

Identifier Source: org_study_id