NCT02582983

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

May 1, 2016

Enrollment Period

5.8 years

First QC Date

October 8, 2015

Results QC Date

May 25, 2016

Last Update Submit

May 25, 2016

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Enfuvirtide

EXPERIMENTAL

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

Drug: Enfuvirtide

Interventions

EnfuvirtideDRUG

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

Also known as: Fuzeon
Enfuvirtide

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bangkok, 10110, Thailand

Location

Unknown Facility

Bangkok, 10330, Thailand

Location

Unknown Facility

Bangkok, 10700, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Unknown Facility

Nonthaburi, 11000, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 21, 2015

Study Start

February 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 6, 2016

Results First Posted

July 6, 2016

Record last verified: 2016-05

Locations

TH(5)