An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment

This study is enrolling participants by invitation only.

First Received: May 8, 2008 Last Updated: June 4, 2008 History of Changes

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
Information provided by:	Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00675844

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: elvucitabine	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: 2',3'-Dideoxy-2',3'-didehydro-5-fluorocytidine Elvucitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ] [ 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 ]

Estimated Enrollment:	25
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
elvucitabine: Experimental 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

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
Nicholaos Bellos, MD
Dallas, Texas, United States, 75204
Central Texas Clinical Research
Austin, Texas, United States, 78705

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:	Achillion Pharmaceuticals, Inc. ( Ronald Gugliotti, MPH )
Study ID Numbers:	ACH443-904
Study First Received:	May 8, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00675844 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Achillion Pharmaceuticals:

Extension study
HIV-1 infection
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009