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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 ]
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 ]
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
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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Dominican Republic,   Germany,   Spain
 
 
NCT00380159
ACH443-018
No
Not Provided
Not Provided
Not Provided
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