HIV infection
Conditions
Interventions
Trade Name: Fuzeon
Pharmaceutical Form: Solution for injection in needle-free injector
INN or Proposed INN: ENFUVIRTIDE
CAS Number: 159519-65-0
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be a current ENF user (uninterrupted ENF = 2 weeks prior to screening) or a former ENF user (discontinued for = 1 week prior to screening) who, in the opinion of the investigator, may benefit from needle-free administration of ENF. 2. Be HIV-1 positive and have disease criteria such that the principal investigator believes the patient would benefit from an ENF-based antiretroviral regimen (e.g. use of ENF with other antiretroviral agents, evidence of HIV-1 replication despite ongoing antiretroviral therapy) 3. Be naïve to the use of the B2000 4. Be willing to use the standard 27G ½” needle and syringe for injections through Week 4 if randomized to NS 5. Be age = 16 years at the time of screening 6. Be willing and able to give written informed consent or have a legal guardian provide written informed consent 7. Female patients of childbearing potential must have a negative serum or urine pregnancy test documented during screening for eligibility, and a negative serum or urine pregnancy test within 24 hours prior to first dose of study medication. Patients in heterosexual relationships where the female is of childbearing potential must agree to use a reliable form of effective contraception (=65 years) no F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study 2. Any current clinical adverse event, which at the discretion of the investigator is deemed clinically inappropriate 3. Evidence of active, untreated opportunistic infections (including any abnormality on fundoscopic examination, unless deemed benign by an ophthalmologist), or unexplained temperature which is greater than or equal to 38.5°C for seven consecutive days, within 30 days prior to the screening visit. Patients who are on a stable anti-infective treatment or prophylaxis regimen are allowed in the study 4. Evidence of alcohol and/or substance abuse within one year of entry that, in the judgment of the investigator, would result in the patient being unreliable in fulfilling the conditions of the protocol 5. Patients with ongoing serious concurrent illness or ongoing adverse events that would interfere with their participation in the trial 6. Patients naïve to ENF 7. Patients who are unable to self-inject ENF or who don’t have a reliable care giver to administer injections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare injection site signs and symptoms associated with enfuvirtide (ENF) injection on needle/syringe (NS) versus B2000 needle-free injection device (NFID) based on a composite endpoint of Grade 1-3 ongoing pain and either (a) Grade 3-4 induration (>25 mm) or (b) Grade 2-4 nodules/cysts (>20 mm) and incidence and severity of individual clinical signs and symptoms of ISR;Secondary Objective: To evaluate the following during self-administration of ENF using the B2000: • ENF safety/tolerability (based on frequency and severity of ISR signs and symptoms) • Overall ENF exposure and time to discontinuation • ENF adherence, patient satisfaction, and preference;Primary end point(s): • Signs and symptoms associated with ENF injections that will be based on a composite endpoint of Grade 1-3 ongoing pain and either (a) Grade 3-4 induration (> 25 mm) or (b) Grade 2-4 nodules/cysts (>20 mm). • Incidence and severity of individual clinical signs and symptoms of ISR;Timepoint(s) of evaluation of this end point: Patients will report to the clinic at baseline, Week 4 (Day 29), and Week 8 (Day 57). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall ISR summary score based on in-clinic signs and symptoms of ISR • Incidence of patients discontinuing the study due to clinical adverse events and ISR Safety Endpoints • Incidence of SAEs/SADEs/Adverse events of special interest • Incidence of adverse events leading to discontinuation • Incidence of deaths;Timepoint(s) of evaluation of this end point: Patients will report to the clinic at baseline, Week 4 (Day 29), and Week 8 (Day 57). | — |
Countries
United States
Contacts
Public ContactRoche Trial Information Hotline
F. Hoffmann-La Roche AG
Outcome results
None listed