Clinical Trials

MainTitle

An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment

This study has been completed
Sponsor
Achillion Pharmaceuticals

Collaborator
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 (Responsible Party)
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier
NCT00675844

First received: May 8, 2008
Last updated: January 20, 2014
Last Verified: January 2014
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : elvucitabine
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures

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

Enrollment: 7
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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

Eligibility

Eligibility

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

Criteria

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.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675844

Locations

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

Investigators

Study Director: Elizabeth Olek, DO Achillion Pharmaceuticals
More Information

More Information


Responsible Party: Ronald Gugliotti, MPH, Achillion Pharmaceuticals, Inc.  
ClinicalTrials.gov Identifier: NCT00675844   History of Changes  
Other Study ID Numbers: ACH443-904  
Study First Received: May 8, 2008  
Last Updated: January 20, 2014  

Keywords provided by Achillion Pharmaceuticals:

Extension study
HIV-1 infection
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Zalcitabine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.