Raltegravir Intensification in HIV-Infected Patients - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	Merck
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00631449

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Raltegravir Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Raltegravir Intensification in Antiretroviral-Treated Patients Exhibiting a Suboptimal CD4+ T Cell Response

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Raltegravir: Active Comparator 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.	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.
Placebo: Placebo Comparator 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.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631449

Locations

United States, California
San Francisco General Hospital, Clinical Research Center
San Francisco, California, United States, 94110
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121

Sponsors and Collaborators

University of California, San Francisco

Merck

Investigators

Principal Investigator:

Hiroyu Hatano, MD

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( Hiroyu Hatano, MD/Principal Investigator )
Study ID Numbers:	H52899-31393-03
Study First Received:	February 28, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00631449 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

HIV
Treatment intensification
Low level viremia
Suboptimal CD4+ T cell response
treatment experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 20, 2009