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Raltegravir Intensification in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00631449
First received: February 28, 2008
Last updated: October 30, 2015
Last verified: October 2015
History of Changes

February 28, 2008
October 30, 2015
February 2008
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00631449 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Raltegravir Intensification in HIV-infected Patients
Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • 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.
  • 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
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.
 
Completed
30
March 2010
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00631449
H52899-31393-03
Yes
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
Merck Sharp & Dohme Corp.
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
University of California, San Francisco
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP