Fuzeon Viral Decay Pilot Study

Not Applicable

Completed

• Conditions: HIV-1
• Interventions: Drug: enfuvirtide

• Registration Number: NCT00334022
• Lead Sponsor: Canadian Immunodeficiency Research Collaborative

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Primary Completion: 2007-07
• Study Completion: 2010-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Did not receive enfuvirtide	enfuvirtide	patients were randomized to either receive enfuviratide or not receive it
enfuvirtide	enfuvirtide	enfuvirtide 1ml BID

Primary Outcome Measures

Name	Time	Method
The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.	6 months	The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.

Secondary Outcome Measures

Name	Time	Method
To determine the change of proviral HIV-1 DNA from baseline to month 3	3 months	To determine the change of proviral HIV-1 DNA from baseline to month 3
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	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 quantify plasma HIV (limit of detection 2 copies/ml of plasma)	9 months	To quantify plasma HIV (limit of detection 2 copies/ml of plasma)
To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells	9 months	To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells
To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays	9 months	To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays
To determine the half-life of HIV in resting CD4+ T cells	9months	To determine the half-life of HIV in resting CD4+ T cells
To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments	9 months	To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell
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	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)

Trial Locations

Locations (1)

Maple Leaf Medical Clinic; 🇨🇦 Toronto, Ontario, Canada