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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582983
• Other study ID #: ML17819
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: March 22, 2016
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess 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 antiretroviral class, or will have experienced intolerance to previous antiretroviral regimens will receive enfuvirtide, 90 milligrams (mg) subcutaneous (SC) twice daily (BID) as long as there is enfuvirtide related treatment limiting toxicities and patients are beneficial from study treatment as per investigator's discretion. The anticipated time on study treatment is based on the commercial availability of Fuzeon in Thailand, and the target sample size is 30 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Enfuvirtide
All participants will receive enfuvirtide 90 mg SC BID until 4 weeks after commercial availability is established in Thailand.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events (AEs)		Up to 4 weeks after commercial availability of enfuvirtide in Thailand	No
Primary	Incidence of premature withdrawals due to safety events		Up to 4 weeks after commercial availability of enfuvirtide in Thailand	No