Trial record 3 of 11 for:
elvucitabine
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:
Achillion Pharmaceuticals
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00380159
First received: September 21, 2006
Last updated: August 18, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection |
Drug: elvucitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Achillion Pharmaceuticals:
Primary Outcome Measures:
- To assess the safety of 48weeks of 10mg/QD of elvucitabine in combination with ART [ Time Frame: September 2008 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 14 |
| Study Start Date: | September 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: elvucitabine
elvucitabine 10 mg in combination with background ART
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380159
Locations
| United States, Georgia | |
| ARCA | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Ohio | |
| ACTU University of Cincinnati | |
| Cincinnati, Ohio, United States, 45242 | |
| Dominican Republic | |
| Dr. Salvador B Gautier Hospital | |
| Santo Domindo, Dominican Republic | |
| Germany | |
| EPIMED | |
| Berlin, Germany | |
| immunologische Ambulanz, University Clinic | |
| Bonn, Germany | |
| Klinikum der Universitat zu Koln | |
| Koln, Germany | |
| Spain | |
| Hospital La Paz | |
| Madrid, Spain | |
Sponsors and Collaborators
Achillion Pharmaceuticals
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Achillion Pharmaceuticals, Inc., Ronald Gugliotti |
| ClinicalTrials.gov Identifier: | NCT00380159 History of Changes |
| Other Study ID Numbers: | ACH443-018 |
| Study First Received: | September 21, 2006 |
| Last Updated: | August 18, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Achillion Pharmaceuticals:
|
Extension study to ACH443-014A |
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 Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013