Fuzeon Viral Decay Pilot Study

HIV-1 Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334022
• Other study ID #: Roche-FVD-1
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: June 4, 2012
• Start date: February 2006
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• Source: Canadian Immunodeficiency Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• enfuvirtide
1ml BID

Locations

Country	Name	City	State
Canada	Maple Leaf Medical Clinic	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Immunodeficiency Research Collaborative	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.	The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.	6 months	No
Secondary	To determine the change of proviral HIV-1 DNA from baseline to month 3	To determine the change of proviral HIV-1 DNA from baseline to month 3	3 months	No
Secondary	To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm	To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm	9 months	No
Secondary	To quantify plasma HIV (limit of detection 2 copies/ml of plasma)	To quantify plasma HIV (limit of detection 2 copies/ml of plasma)	9 months	No
Secondary	To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells	To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells	9 months	No
Secondary	To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays	To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays	9 months	No
Secondary	To determine the half-life of HIV in resting CD4+ T cells	To determine the half-life of HIV in resting CD4+ T cells	9months	No
Secondary	To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments	To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell	9 months	No
Secondary	To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)	To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)	9 months	No