An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment

This study has been completed.
Sponsor:
Collaborators:
Bellos, Nicholaos C., M.D.
Central Texas Primary Care Research Network
Orlando Immunology Center
Saint Michael
Center for the Prevention and Treatment of Infections
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00675844
First received: May 8, 2008
Last updated: January 20, 2014
Last verified: January 2014

May 8, 2008
January 20, 2014
May 2008
March 2010   (final data collection date for primary outcome measure)
Determine the safety profile of elvucitabine as measured by the incidence of study discontinuations and the incidence, severity and type of AEs and clinically significant changes or abnormalities in the subject's clinical laboratory results. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675844 on ClinicalTrials.gov Archive Site
Determination of the continued efficacy of elvucitabine as measured by the change in helper T cell (CD4) count. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment
An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment for 48-Weeks in Subjects Who Have Completed 96 -Weeks of Elvucitabine Therapy in Protocol ACH443-015 or 48 Weeks of Therapy in Protocol ACH443-018

Extension study for subjects currently participating in protocols ACH443-015 and ACH443-018.

HIV-1-infected, clinically stable, treatment-naïve adults who have completed 96-weeks of elvucitabine therapy in protocol ACH443-015 and whose HIV RNA levels remain below 50 copies/mL from the 92-week assessment in protocol ACH443-015 or subjects who have completed 48-weeks of elvucitabine therapy in protocol ACH443-018 and continue to maintain a HIV-1 RNA viral load below their baseline level upon entry into protocol ACH443-018

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: elvucitabine
10 mg elvucitabine daily as part of an ART regimen
Experimental: elvucitabine
Subjects currently receiving elvucitabine will continue elvucitabine as part of their ART regimen for an additional 48 months.
Intervention: Drug: elvucitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00675844
ACH443-904
No
Ronald Gugliotti, MPH, Achillion Pharmaceuticals, Inc.
Achillion Pharmaceuticals
  • Bellos, Nicholaos C., M.D.
  • Central Texas Primary Care Research Network
  • Orlando Immunology Center
  • Saint Michael
  • Center for the Prevention and Treatment of Infections
Study Director: Elizabeth Olek, DO Achillion Pharmaceuticals
Achillion Pharmaceuticals
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP