Open-Label, 48 Week Extension Study of Elvucitabine in Combination With Background ART For Subjects Who Have Completed Study ACH443-014A

This study has been completed.
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00380159
First received: September 21, 2006
Last updated: February 18, 2014
Last verified: February 2014

September 21, 2006
February 18, 2014
September 2006
December 2008   (final data collection date for primary outcome measure)
To assess the safety of 48weeks of 10mg/QD of elvucitabine in combination with ART [ Time Frame: September 2008 ] [ Designated as safety issue: No ]
To assess the safety of 24 weeks of 10mg/QD of elvucitabine in combination with ART
Complete list of historical versions of study NCT00380159 on ClinicalTrials.gov Archive Site
To describe the anti-viral activity of elvucitabine in combination with ART as measured by plasma HIV-1 RNA over 24 weeks [ Time Frame: September 2008 ] [ Designated as safety issue: No ]
To describe the anti-viral activity of elvucitabine in combination with ART as measured by plasma HIV-1 RNA over 24 weeks
Not Provided
Not Provided
 
Open-Label, 48 Week Extension Study of Elvucitabine in Combination With Background ART For Subjects Who Have Completed Study ACH443-014A
An Open-Label,48 Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Subjects Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.

To assess the safety of 48 weeks of treatment with 10 mg of elvucitabine in combination with background ART in subjects who completed protocol ACH443-014A and meet the inclusion and exclusion criteria.

This study is an open-label extension study for subjects who have completed 14 days of treatment in protocol ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10mg) will begin on Day 1 (Day 15 following completion of protocol ACH443-014A) for all consented subjects in combination with background ART as determined by the principal investigator. Subjects will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to week 48.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
  • Drug: elvucitabine
    elvucitabine 10 mg in combination with background ART
  • Drug: Lamivudine
  • Drug: Emtricitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Dominican Republic,   Germany,   Spain
 
NCT00380159
ACH443-018
No
Achillion Pharmaceuticals, Inc., Ronald Gugliotti
Achillion Pharmaceuticals
Not Provided
Principal Investigator: Michael Saag, MD Aids Out-Ptient Clinic University of Alabama
Principal Investigator: Richard Pollard, MD Division of ID University of CA Davis
Principal Investigator: Donna Mildvan, MD ACTU Beth Israel Medical Center
Principal Investigator: Judit Fienberg, MD University of Cincinnati
Principal Investigator: D Jayaweera, MD ID Research Unit University of Miami
Principal Investigator: Edwin DeJesus, MD Orlando Immunology Center
Principal Investigator: Melanie Thompson, MD ARCA Atlanta Georgia
Achillion Pharmaceuticals
February 2014

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