DRUG
Enfuvirtide
All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Status
Completed
Phase
Phase 4
Enrollment
23
Locations
5
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 21, 2015
Study start
Feb 2004
Primary completion
Dec 2009
Study completion
Dec 2009
Results posted
Jul 6, 2016
Registry updated
Jul 6, 2016
Outcomes
What the study measures.
Primary outcomes
Number of Participants With Serious Adverse Events (SAEs)
Time frame · Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
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.
Number of Participants With Premature Withdrawal Due to Adverse Events
Time frame · Up to 96 weeks
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
5 registered sites.
Thailand. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Bangkok, Thailand
Facility not named
Bangkok, Thailand
Facility not named
Bangkok, Thailand
Facility not named
Chiang Mai, Thailand
Facility not named
Nonthaburi, Thailand
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Enfuvirtide.
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Related PeptideStat pages
Put the record in context.
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