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: Powd
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected adults ( > 18 years of age) previously treated with 2 or 3 different ARV classes with a CD4 lymphocyte count =200 cells/mm3 and HIV-1 RNA = 1,000 copies/mL, while on their current “pre-study”ARV regimen 2. Must currently be on ARV therapy, with no changes to that regimen for > 4 weeks prior to entering screening (patients on treatment interruption excluded). Patients must remain on their “pre-study”regimen unchanged except for toxicity management until BL1 3. Must be able to create a study HAART regimen with at least 2 ARVs to which his/her virus show sensitivity by genotypic testing at screening (Genotypic Sensitivity Score or GSS =2). 4. Must be willing and able to give written informed consent 5. Must be willing and able to abide by the conditions of the protocol, including the possibility of being randomized to HAART or ENF+HAART as described in the Induction Phase as well as possibly being randomized to either stop or continue ENF in the Maintenance Phase 6. Female subjects of childbearing potential must have a negative serum pregnancy test documented during screening for eligibility, and a negative urine pregnancy test within 24 hours prior to first dose of study medication. Female subjects of childbearing potential must agree to use a reliable form of effective barrier contraception (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Expected systemic hypersensitivity to enfuvirtide or to any of the excipients of the investigational medicinal product. 2. History of prior use of enfuvirtide and/or T-1249 3. Patients for whom standard of care, in the judgment of the investigator, would require immediate use of enfuvirtide or medications not permitted in the protocol. 4. Patients on treatment interruption or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons other than toxicity management. 5. Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study. 6. Any current clinical parameter of ACTG Grade 3 or laboratory parameter of ACTG Grade 4. Stable current clinical parameter of ACTG Grade 3 or Asymptomatic Grade 4 laboratory abnormalities will be permitted, at the discretion of the investigator (and following approval by the sponsor), if deemed clinically appropriate. 7. Evidence of alcohol and/or drug (illicit or prescription) abuse within one year of entry that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol. 8. Prior non-adherence to antiretroviral treatment regimens that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol. 9. Inability to self-inject enfuvirtide as indicated in the protocol unless a care giver or partner/family member is available to be trained and to administer the injections for the duration of the study. 10. Current severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. 11. Major organ allograft. 12. Evidence of active, untreated opportunistic infection (including any abnormality on fundoscopic examination, unless deemed benign by an ophthalmologist), or unexplained temperature which is greater than or equal to 38.5 degrees C for seven consecutive days, within 30 days prior to the screening visit. Subjects who are on a stable anti-infective treatment or prophylaxis regimen are allowed in the study. 13. Currently taking or anticipated to take during the course of the study, any immunomodulator, HIV vaccine, or investigational agent for any conditions other than HIV/AIDS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the induction strategy of HAART alone (I1) compared to enfuvirtide (90 mg s.c.BID) in combination with HAART (ENF+HAART, I2) • To determine the overall induction/maintenance treatment strategy (with or without continued ENF) after 48 weeks of treatment • To compare different maintenance strategies for those patients who are qualified for entering the maintenance phase (M1, M2 and M3) • To assess the safety of induction phase (I1 vs I2) and maintenance phase (M1, M2, and M3). ;Secondary Objective: ;Primary end point(s): The following two endpoints will be used to assess the virological response at week 24: • Percent of patients initially achieving viral suppression to < 50 copies/mL or • Percent of patients initially achieving viral suppression to < 400 copies/mL. In order to compare how soon patients will respond to the randomized treatment, the time to achieving initial viral suppression to < 50 copies/mL at week 24 will be used. For analyzing continuous endpoints: • Change from baseline in log10 (HIV-1 RNA) at week 24 or • Change from baseline in CD4 counts at week 24. At week 48: In order to compare induction/maintenance strategies for patients with or without continued ENF in their treatment regimen, the percent of patients achieving viral suppression < 50 copies/mL prior to or at week 48 will be used. For comparison of maintenance strategies, the time-to-loss virological response (i.e. 2 consecutive viral load values = 50 copies/mL) will be the primary efficacy endpoint. Safety assessment will be based on comparison of the number and percent of patients that have specified events (pneumonias, SAEs and serious SAEs) during each of the treatment phases. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed