A Phase 2 Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Gilead Sciences.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: March 15, 2011
Last verified: January 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 28, 2007 | ||||
| Last Updated Date | March 15, 2011 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Adverse Events [ Designated as safety issue: Yes ] The incidence of study drug related, treatment emergent adverse events |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00445146 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 | A Phase 2 Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects | ||||
| Official Title ICMJE | A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects | ||||
| Brief Summary | This study is being initiated to provide continued access to GS-9137/r for those subjects currently benefiting from their participation in an ongoing GS-9137/r study. This study will also provide initial access to GS-9137/r for those subjects who have completed a GS-9137/r study in which the subject was participating in a treatment arm that did not include GS-9137/r. This study will continue to monitor the safety and tolerability of GS-9137/r through periodic assessment of adverse events, changes in concomitant medications and clinical laboratory tests. This study is an open-label study. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Drug: GS-9137
GS-9137 administered orally with ritonavir, once daily with food in combination with other antiretroviral agents
Other Name: elvitegravir |
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| Study Arm (s) | Experimental: GS-9137
Intervention: Drug: GS-9137 |
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| 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 | Active, not recruiting | ||||
| Enrollment ICMJE | 122 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Puerto Rico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00445146 | ||||
| Other Study ID Numbers ICMJE | GS-US-183-0130 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Martin Rhee, MD /Associate Director Clinical Research, Gilead Sciences, Inc | ||||
| Study Sponsor ICMJE | Gilead Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Gilead Sciences | ||||
| Verification Date | January 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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