Back to resultsOpen-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
Primary Purpose
Human Immunodeficiency Virus (HIV)-1 Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elvucitabine
Lamivudine
Emtricitabine
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus (HIV)-1 Infection focused on measuring Extension study to Study ACH443-014A
Eligibility Criteria
Inclusion Criteria:
- Subjects who have completed 14 days of treatment in ACH443-014A and who, in the investigator's judgment, remain candidates to receive elvucitabine together with background antiretroviral therapy.
Exclusion Criteria:
- Failure to meet inclusion criteria
Sites / Locations
- Clinical Trial Site
- Clinical Trial Site
- Clinical Trial Site
- Clinical Trial Site
- Clinical Trial Site
- Clinical Trial Site
- Clinical Trial Site
Outcomes
Primary Outcome Measures
To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
Secondary Outcome Measures
To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks
Full Information
NCT ID
NCT00380159
First Posted
September 21, 2006
Last Updated
August 7, 2023
Sponsor
Alexion
Collaborators
Achillion, a wholly owned subsidiary of Alexion
1. Study Identification
Unique Protocol Identification Number
NCT00380159
Brief Title
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
Official Title
An Open-Label, 48-Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Participants Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
Collaborators
Achillion, a wholly owned subsidiary of Alexion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.
Detailed Description
This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)-1 Infection
Keywords
Extension study to Study ACH443-014A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Elvucitabine
Intervention Description
Elvucitabine 10 mg in combination with background ART
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Emtricitabine
Primary Outcome Measure Information:
Title
To Assess The Safety Of 48 Weeks Of 10 mg/daily (QD) Of Elvucitabine In Combination With ART
Time Frame
September 2008
Secondary Outcome Measure Information:
Title
To Describe The Anti-viral Activity Of Elvucitabine In Combination With ART As Measured By Plasma HIV-1 Ribonucleic Acid (RNA) Over 24 Weeks
Time Frame
September 2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.
Exclusion Criteria:
Failure to meet inclusion criteria
Facility Information:
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Clinical Trial Site
City
Santo Domingo
Country
Dominican Republic
Facility Name
Clinical Trial Site
City
Berlin
Country
Germany
Facility Name
Clinical Trial Site
City
Bonn
Country
Germany
Facility Name
Clinical Trial Site
City
Köln
Country
Germany
Facility Name
Clinical Trial Site
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A
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