Raltegravir Intensification in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00631449 |
Recruitment Status
:
Completed
First Posted
: March 7, 2008
Results First Posted
: December 30, 2013
Last Update Posted
: November 3, 2015
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Sponsor:
University of California, San Francisco
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco
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Tracking Information | ||||
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First Submitted Date ICMJE | February 28, 2008 | |||
First Posted Date ICMJE | March 7, 2008 | |||
Results First Submitted Date | November 12, 2013 | |||
Results First Posted Date | December 30, 2013 | |||
Last Update Posted Date | November 3, 2015 | |||
Study Start Date ICMJE | February 2008 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
We Will Use as Our Primary Endpoint the Proportion of Subjects in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12. [ Time Frame: Week 12 ] | |||
Original Primary Outcome Measures ICMJE |
We will use as our primary endpoint the proportion of subjects in each group (study drug vs. placebo) with undetectable plasma HIV-1 RNA, as measured by an ultra-sensitive assay with a limit of detection of 1 copy/mL at week 4. [ Time Frame: Week 4 ] | |||
Change History | Complete list of historical versions of study NCT00631449 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) Will be Assessed as a Secondary Outcome. [ Time Frame: Week 24 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Raltegravir Intensification in HIV-infected Patients | |||
Official Title ICMJE | Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response | |||
Brief Summary | The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Hatano H, Hayes TL, Dahl V, Sinclair E, Lee TH, Hoh R, Lampiris H, Hunt PW, Palmer S, McCune JM, Martin JN, Busch MP, Shacklett BL, Deeks SG. A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. J Infect Dis. 2011 Apr 1;203(7):960-8. doi: 10.1093/infdis/jiq138. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | March 2010 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00631449 | |||
Other Study ID Numbers ICMJE | H52899-31393-03 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of California, San Francisco | |||
Study Sponsor ICMJE | University of California, San Francisco | |||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | |||
Investigators ICMJE |
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PRS Account | University of California, San Francisco | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |