A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: enfuvirtide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02569502

ML18634

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Enfuvirtide

Experimental group

Description:

Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections

Treatment:

Drug: enfuvirtide