An Open Label Treatment Protocol to Provide Continued Elvucitabine Treatment
This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00675844
First received: May 8, 2008
Last updated: January 20, 2014
Last verified: January 2014
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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 (Adult) |
| 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
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
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016