Trial record 19 of 30 for:    " April 30, 2008":" May 30, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014