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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enfuvirtide

Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).

Group Type EXPERIMENTAL

Enfuvirtide

Intervention Type DRUG

All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.

Interventions

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Enfuvirtide

All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.

Intervention Type DRUG

Other Intervention Names

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Fuzeon

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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No