We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00675844
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : February 13, 2014
Information provided by:

Study Description
Brief Summary:
Extension study for subjects currently participating in protocols ACH443-015 and ACH443-018.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: elvucitabine Phase 2

Detailed Description:
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: elvucitabine
Subjects currently receiving elvucitabine will continue elvucitabine as part of their ART regimen for an additional 48 months.
Drug: elvucitabine
10 mg elvucitabine daily as part of an ART regimen

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determination of the continued efficacy of elvucitabine as measured by the change in helper T cell (CD4) count. [ Time Frame: 48 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675844

United States, Florida
Orlando Immunology Center
Orlando, Florida, United States, 32803
Center for the Prevention and Treatment of Infections
Pensacola, Florida, United States, 32504
United States, New Jersey
St Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Nicholaos Bellos, MD
Dallas, Texas, United States, 75204
Sponsors and Collaborators
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
More Information

Responsible Party: Ronald Gugliotti, MPH, Achillion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00675844     History of Changes
Other Study ID Numbers: ACH443-904
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: January 2014

Keywords provided by Achillion Pharmaceuticals:
Extension study
HIV-1 infection
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents