Heavily drug experienced HIV infected patients at switch of anti- HIV therapy.
Conditions
Interventions
Trade Name: Fuzeon
Product Name: Fuzeon
Product Code: T-20
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Penine Acute NHS Trust, North Manchester General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Prior experience to Nuceloside Reverse Transcriptase Inhibitors + Non-Nucleoside Reverse Transcriptase Inhibitors +Protease Inhibitors, or 2). Resistance in >2 classes, or 3). Significant >1 class toxicity 4). HIV-1 RNA >1000 copies/ml 5). Any CD4 cells/mm3 6). Age 18 or over Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1). Prior experience to Nuceloside Reverse Transcriptase Inhibitors + Non-Nucleoside Reverse Transcriptase Inhibitors +Protease Inhibitors, or 2). Resistance in >2 classes, or 3). Significant >1 class toxicity 4). HIV-1 RNA >1000 copies/ml 5). Any CD4 cells/mm3 6). Age 18 or over Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1). Active infection under investigation or treatment 2). Predicted poor adherence or poor attender 3). Pregnancy or breast feeding 4). On-going or previous treatment with enfuvirtide 5). Malignancy requiring systemic chemotherapy 6). Hb 2 times upper limit of normal (ULN), ALT > 5 times ULN, bilirubin >2 times ULN, amylase > 2 times ULN. 7). Karnofsky score >70 ;Exclusion criteria: 1). Active infection under investigation or treatment 2). Predicted poor adherence or poor attender 3). Pregnancy or breast feeding 4). On-going or previous treatment with enfuvirtide 5). Malignancy requiring systemic chemotherapy 6). Hb 2 times upper limit of normal (ULN), ALT > 5 times ULN, bilirubin >2 times ULN, amylase > 2 times ULN. 7). Karnofsky score >70
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the potential of using 24 week induction with enfuvirtide and optimised background anti-HIV therapy to produce a significant and sustained increase in CD4+ count in heavily drug experienced HIV infected patients at switch of therapy. ;Secondary Objective: Secondary: To assess the kinetics of VL, CD4, metabolic markers, progression to AIDS/death and toxicity and adverse events ;Primary end point(s): Primary negative endpoint of virological failure and positive end point of significant and sustained increase in CD4+ count and decrease in viral load;Main Objective: To assess the potential of using 24 week induction with enfuvirtide and optimised background anti-HIV therapy to produce a significant and sustained increase in CD4+ count in heavily drug experienced HIV infected patients at switch of therapy. ;Secondary Objective: Secondary: To assess the kinetics of VL, CD4, metabolic markers, progression to AIDS/death and toxicity and adverse events ;Primary end point(s): Primary negative endpoint of virological failure and positive end point of significant and sustained increase in CD4+ count and decrease in viral load | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed