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An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elvucitabine
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Extension study, HIV-1 infection, Treatment naive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 OR subjects have completed 48-weeks of elvucitabine therapy in protocol ACH443-014A / 018.

Exclusion Criteria:

  • Subject has experienced viroligic rebound as defined in section 5.6.1.3 of protocol ACH443-015.
  • Subject has exceeded their baseline HIV-1 RNA level by Week 44 as measured in protocol ACH443-014A / 018
  • Subject is experiencing a drug-related Grade 3 or 4 rash or a drug related grade 3 or 4 laboratory toxicity other than Grade 3 or 4 cholesterol, triglyceride,creatinine kinase, or LDH.

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elvucitabine

Arm Description

Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months.

Outcomes

Primary Outcome Measures

Determine Safety Profile Of Elvucitabine Measured By Incidence Of Study Discontinuations And Incidence, Severity, And Type Of Adverse Events And Clinically Significant Changes Or Abnormalities In Participant's Clinical Laboratory Results.

Secondary Outcome Measures

Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.

Full Information

First Posted
May 8, 2008
Last Updated
August 7, 2023
Sponsor
Alexion
Collaborators
Achillion, a wholly owned subsidiary of Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT00675844
Brief Title
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
Official Title
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment for 48 Weeks in Participants Who Have Completed 96 Weeks of Elvucitabine Therapy in Protocol ACH443-015 or 48 Weeks of Therapy in Protocol ACH443-018
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (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
Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.
Detailed Description
Human immunodeficiency virus (HIV)-1-infected, clinically stable, treatment-naïve adult participants who have completed 96 weeks of elvucitabine therapy and whose HIV ribonucleic acid (RNA) levels remain below 50 copies/milliliter (mL) at the 92-week assessment in Protocol ACH443-015 or participants who have completed 48 weeks of elvucitabine therapy and continue to maintain an HIV-1 RNA viral load below their baseline level upon entry into Protocol ACH443-018.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Extension study, HIV-1 infection, Treatment naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elvucitabine
Arm Type
Experimental
Arm Description
Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months.
Intervention Type
Drug
Intervention Name(s)
Elvucitabine
Intervention Description
10 milligrams (mg) elvucitabine daily as part of an ART regimen
Primary Outcome Measure Information:
Title
Determine Safety Profile Of Elvucitabine Measured By Incidence Of Study Discontinuations And Incidence, Severity, And Type Of Adverse Events And Clinically Significant Changes Or Abnormalities In Participant's Clinical Laboratory Results.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 . Exclusion Criteria: Participant has experienced virologic rebound as defined in Section 5.6.1.3 of Protocol ACH443-015. Participant has exceeded their Baseline HIV-1 RNA level by Week 44 as measured in Protocol ACH443-014A-018 Participant is experiencing a drug-related Grade 3 or 4 rash or a drug-related Grade 3 or 4 laboratory toxicity other than Grade 3 or 4 cholesterol, triglyceride, creatinine kinase, or lactate dehydrogenase (LDH).
Facility Information:
Facility Name
Clinical Trial Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Clinical Trial Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Clinical Trial Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment

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