A 24 week, open label single arm study to evaluate the safety and efficacy of switching a toxicity causing antiretroviral (ARV) to enfuvirtide (ENF) and to assess resolution or improvement of ARV toxicities in patients with current, historical treatment-limiting toxicities - SWITCH TOX study

Conditions: HIV infection
Classification code 10020161

Registration Number: EUCTR2004-001224-21-DE

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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

• 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.