Clinical trial NCT00631449: Raltegravir Intensification in HIV-infected Patients
Official title: Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
Treatment intensification
Low level viremia
Suboptimal CD4+ T cell response
treatment experienced
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants 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.
timeFrame: Week 12
Secondary outcomes:
measure: Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital, Clinical Research Center
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steven Deeks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.