Back to resultsRaltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Raltegravir
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1 infection, raltegravir, immune discordance, treatment experienced
Eligibility Criteria
Inclusion Criteria:
- Documented HIV-1 infection.
- Subject has voluntarily signed and dated an informed consent form.
- Documented sustained HIV RNA < 50 copies/ml (two consecutive pVL < 50 copies/ml, first VL > 12 months before the screening date) without documentation of HIV RNA > 50 copies/ml for at least 12 months while on previous stable HAART (PS_HAART).
- HIV RNA < 50 copies/ml at screening.
- Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 months.
- CD4 count < 200 cells/ mm3 AND CD4 increase < 100 cells/ mm3 in the last 12 months.
- Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- Negative serum or urine pregnancy test and willing to use acceptable means of contraception.
Exclusion Criteria:
- Patient is receiving tenofovir DF AND didanosine as a component of the background antiretroviral therapy.
- Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
- Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic, or hepatic disease or any condition that, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
- Subject has a currently active AIDS defining illness (category C conditions according to the CDC Classification System for HIV infection 1993) within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled.
- Life expectancy < 1 year according to the judgment of the investigator.
Screening laboratory analysis show any of the following abnormal laboratory results:
- Hemoglobin < 8.0 g/dL
- Absolute neutrophil count < 750 cells/µL
- Platelet count < 50,000 mm3
- Use of any investigational agents within 30 days prior to screening.
- Previous use of integrase inhibitors.
- Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last year.
- Continuous use of systemic corticoids for more than a month in the last year or any use in the last 3 months.
- Subject has an ongoing history of substance abuse or psychiatric illness.
- Subject is pregnant or breast-feeding.
Sites / Locations
- Fundacion Huesped
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Raltegravir
Raltegravir matching placebo
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Secondary Outcome Measures
Proportion of patients achieving plasma HIV-RNA < 5 copies/ml.
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Proportion of patients achieving CD4 count > 250 cells/mm3
Proportion of patients achieving an increase of 5 percentual points in CD4 percentage
Median change from baseline in CD4 count.
Proportion of patients maintaining HIV RNA <50 copies/ml.
Full Information
NCT ID
NCT00562510
First Posted
November 21, 2007
Last Updated
June 5, 2015
Sponsor
Pedro Cahn
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00562510
Brief Title
Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
Official Title
A Phase 3, Randomized, Double Blinded, Placebo Controlled Study of Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
recruitment lower than estimated
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Cahn
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare the safety, tolerability, antiviral activity and immunological effect of raltegravir added to a previously stable HAART regimen in the treatment of HIV-1 infected subjects with undetectable viraemia and low CD4 recovery.
HYPOTHESIS:
Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.
Detailed Description
Although HAART has reduced the morbidity and mortality from HIV-1 infection, some patients experience a discordant response characterized by HIV-1 RNA plasma levels below the limit of detection and low CD4 T-cell recovery (immunologic discordant responders). At present, recommendations for the clinical management of patients with discordant responses to antiretroviral therapy are largely based on observational, uncontrolled data.
The effect on CD4 count of adding raltegravir in already undetectable patients has not yet been evaluated.
The primary purpose of this study is to assess the ability of the HIV-1 integrase inhibitor, raltegravir, added to a stable HAART, to increase CD4 count in patients with undetectable plasma viral load and low CD4 recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1 infection, raltegravir, immune discordance, treatment experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raltegravir
Arm Type
Experimental
Arm Title
Raltegravir matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Raltegravir
Intervention Description
Raltegravir 400 mg BID added to stable HAART
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID added to stable HAART
Primary Outcome Measure Information:
Title
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients achieving plasma HIV-RNA < 5 copies/ml.
Time Frame
48 weeks
Title
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Time Frame
24 weeks
Title
Proportion of patients achieving CD4 count > 250 cells/mm3
Time Frame
48 weeks
Title
Proportion of patients achieving an increase of 5 percentual points in CD4 percentage
Time Frame
48 weeks
Title
Median change from baseline in CD4 count.
Time Frame
48 weeks
Title
Proportion of patients maintaining HIV RNA <50 copies/ml.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented HIV-1 infection.
Subject has voluntarily signed and dated an informed consent form.
Documented sustained HIV RNA < 50 copies/ml (two consecutive pVL < 50 copies/ml, first VL > 12 months before the screening date) without documentation of HIV RNA > 50 copies/ml for at least 12 months while on previous stable HAART (PS_HAART).
HIV RNA < 50 copies/ml at screening.
Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 months.
CD4 count < 200 cells/ mm3 AND CD4 increase < 100 cells/ mm3 in the last 12 months.
Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
Negative serum or urine pregnancy test and willing to use acceptable means of contraception.
Exclusion Criteria:
Patient is receiving tenofovir DF AND didanosine as a component of the background antiretroviral therapy.
Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 x upper limit of normal (ULN) AND/OR is likely to require treatment in the next year.
Subject has significant history of cardiac, renal, neurologic, psychiatric, oncologic, metabolic, or hepatic disease or any condition that, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
Subject has a currently active AIDS defining illness (category C conditions according to the CDC Classification System for HIV infection 1993) within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled.
Life expectancy < 1 year according to the judgment of the investigator.
Screening laboratory analysis show any of the following abnormal laboratory results:
Hemoglobin < 8.0 g/dL
Absolute neutrophil count < 750 cells/µL
Platelet count < 50,000 mm3
Use of any investigational agents within 30 days prior to screening.
Previous use of integrase inhibitors.
Use of immunosuppressive drugs, cytokine inhibitors or other cytokines in the last year.
Continuous use of systemic corticoids for more than a month in the last year or any use in the last 3 months.
Subject has an ongoing history of substance abuse or psychiatric illness.
Subject is pregnant or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro E Cahn, MD, PhD
Organizational Affiliation
Fundacion Huesped
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Huesped
City
Buenos Aires
ZIP/Postal Code
1202
Country
Argentina
12. IPD Sharing Statement
Links:
URL
http://www.huesped.org.ar
Description
Fundacion Huesped
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Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
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