A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

Study Overview
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Brief Summary
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This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.

Official Title
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An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Enfuvirtide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals at least 16 years of age infected with HIV-1 CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART) Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens Exclusion Criteria: Evidence of ongoing alcohol and/or drug or substance abuse Prior non-adherence to antiretroviral treatment regimens Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enfuvirtide<br>Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID). | Drug: Enfuvirtide<br>* All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.<br>* Other names: Fuzeon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs) | A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe. | Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) | 
| Number of Participants With Premature Withdrawal Due to Adverse Events |  | Up to 96 weeks |