Raltegravir Intensification in HIV-infected Patients

Tracking Information
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; (submitted: November 12, 2013)	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; (submitted: March 6, 2008)	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; (submitted: March 6, 2008)	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
Condition ICMJE	HIV Infections
Intervention ICMJE	Drug: Raltegravir For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.; Drug: Placebo For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
Study Arms	Active Comparator: Raltegravir For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. Intervention: Drug: Raltegravir; Placebo Comparator: Placebo For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. Intervention: Drug: Placebo
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 6, 2008)	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: Stable antiretroviral therapy for at least 12 months; Screening CD4+ T cell count < 350 cells/mm3; All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3; Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).; >90% adherence to therapy within the preceding 30 days, as determined by self-report; Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. Exclusion Criteria: Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason; Serious illness requiring hospitalization or parental antibiotics within preceding 3 months; **Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period; Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks; Concurrent treatment with phenobarbital, phenytoin, or rifampin.; Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute; Pregnant or breastfeeding women
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
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