A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
- Registration Number
- NCT02569502
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Adult or adolescent patients greater than (>)16 years of age
- HIV-1 infection
- CD4 count less than (<)350/cubic millimeters (mm^3)
- HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
- Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Exclusion Criteria
- Women who are pregnant or breastfeeding;
- Patients unable to self-inject;
- Active, untreated opportunistic infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enfuvirtide enfuvirtide Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
- Primary Outcome Measures
Name Time Method Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events Up to 102 weeks Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections Up to 102 weeks Percentage of participants who discontinue enfuvirtide due to adverse events\n Up to 102 weeks
- Secondary Outcome Measures
Name Time Method Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR Up to 102 weeks Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug Up to 28 days after discontinuation of enfuvirtide