Raltegravir Intensification in HIV-infected Patients - Full Text View

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

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 12. [ Time Frame: Week 12 ] [ 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
Study Completion Date:	March 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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 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.	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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.

Investigators


Principal Investigator:	Hiroyu Hatano, MD	University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00631449 History of Changes
Other Study ID Numbers:	H52899-31393-03
Study First Received:	February 28, 2008
Results First Received:	November 12, 2013
Last Updated:	October 30, 2015
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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016