SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Clinical Alliance for Research & Education - Infectious Diseases, LLC..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Collaborator:
GlaxoSmithKline
Information provided by:
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
ClinicalTrials.gov Identifier:
NCT00426296
First received: January 23, 2007
Last updated: October 30, 2007
Last verified: October 2007
| Tracking Information | |||||
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| First Received Date ICMJE | January 23, 2007 | ||||
| Last Updated Date | October 30, 2007 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00426296 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | SHARE: Simple HAART With Abacavir, Reyataz, and Epivir | ||||
| Official Title ICMJE | An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks | ||||
| Brief Summary | SHARE: Simple HAART with Abacavir, Reyataz, and Epivir |
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| Detailed Description | Open-label, multicenter study of ABC/3TC + ATV in subjects who have completed at least 24 weeks of treatment on ABC/3TC+ATV/RTV as their first line regimen and have plasma HIV-1 RNA <50 copies/mL at entry |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00426296 | ||||
| Other Study ID Numbers ICMJE | COL102060 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Clinical Alliance for Research & Education - Infectious Diseases, LLC. | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | Clinical Alliance for Research & Education - Infectious Diseases, LLC. | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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