An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment
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| ClinicalTrials.gov Identifier: NCT00675844 |
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Recruitment Status
:
Completed
First Posted
: May 12, 2008
Last Update Posted
: February 13, 2014
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Sponsor:
Achillion Pharmaceuticals
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
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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 |
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 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 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | March 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: elvucitabine
Subjects currently receiving elvucitabine will continue elvucitabine as part of their ART regimen for an additional 48 months.
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Drug: elvucitabine
10 mg elvucitabine daily as part of an ART regimen
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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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| 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.
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
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 |
| 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:
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Extension study HIV-1 infection Treatment Naive |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zalcitabine |
Antimetabolites 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 |