HIV infection Classification code 10020161
Conditions
Interventions
Trade Name: Fuzeon 90 mg/ml powder and solvent for solution for injection
Product Name: Fuzeon 90 mg/ml powder and solvent for solution for injection
Product Code: Ro 29-9800
Pharmaceutical Form: Pow
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability to provide informed consent • Patients must be HIV-1 infected adults and triple-class experienced (NRTI, NNRTI, PI ) • Experienced = prior 12 ARVs in their HIV treatment • Patients who have current or prior treatment-limiting toxicities attributed to any ARV and who are still continuing on the offending ARV, or who have interrupted treatment (within 4 weeks prior to baseline day 1) due to any acute offending ARV related toxicity and who are willing to recommence their regimen combination minus the primary offending toxicity causing ARV while adding ENF to that regimen. • Patient must be willing to switch the toxicity causing ARV for ENF at baseline and must be willing to inject ENF subcutaneously BID. 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: • Prior exposure to enfuvirtide • Patients who need to change the entire treatment regimen during screening prior to baseline day 1. • Inability to self-inject (exception: if necessary, health care practitioner may administer injections or a caregiver if available, must be trained to administer the injections for the duration of the study) • Evidence of active opportunistic infection, intercurrent illness or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen • Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study • Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol • Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol • At the physician’s discretion, patients with Grade 4 AEs at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the resolution or severity change of the offending ARV toxicity or new episodes of previous ARV toxicity after the toxicity causing ARV is switched to ENF at baseline. For the purpose of this study the offending toxicities will be stratified into two categories. Category l • Abnormal Liver Function Tests • Gastro Intestinal Toxicity (nausea, vomiting and /or diarrhea) • Lipid abnormalities • Hyperglycemia Category 2 • Pancreatitis • Lactic Acidosis / Hepatic Steatosis • Peripheral Neuropathy • Hepatotoxity ;Secondary Objective: 1) To assess the safety and tolerability of an ENF-based regimen over 24 weeks after the toxicity causing ARV is switched to ENF at baseline. • Treatment emergent abnormal laboratory tests • Discontinuations • Serious Adverse events • AIDS Defining Event’s Category C that are considered serious (appendix 7, see protocol) • Deaths 2) To assess the maintenance of efficacy of an ENF based regimen at 24 weeks after the toxicity causing ARV is switched to ENF at baseline. • Proportion of patients who maintained or improved viral load response using mutually exclusive categories <50, = 50 copies but <400 or = 400 copies/ml at 24 weeks • Proportion of patients who maintain or improve baseline CD4 counts • Quality of life: Mean score changes from baseline in MOS-HIV instrument 3) Adherence – 4 day recall questionnaire. ;Primary end point(s): ARV toxicity: • Grading of severity of current ARV toxicity by ACTG criteria, AHA guidelines or Table 3 (see protocol) • Assessment of change from baseline measurement in addition to grading severity and/or resolution of current ARV toxicities by ACTG, AHA Guidelines criteria or Table 3 (see protocol) over 24 weeks as: - Documentation of prior ARV toxicities at baseline and assessment of new episodes of ARV toxicities over 24 weeks recorded as adverse events - Laboratory tests; hematology, blood chemistry, LFTs, fasting lipids profiles and glucose, changes in values will be measu | — |
Countries
Germany, Italy, Spain
Outcome results
None listed