A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749580
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : July 22, 2014
Last Update Posted : December 17, 2014
Merck Sharp & Dohme Corp.
St. Joseph's Hospital, Florida
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The purpose of this study is to determine whether raltegravir 400 mg b.i.d. in a boosted PI regimen is as efficacious and safe as the NRTI backbone in a boosted PI regimen.

Condition or disease Intervention/treatment Phase
Virus Diseases HIV Drug: Switch NRTIs as a Backbone to Raltegravir Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Patients Switched From a Stable Boosted PI Regimen
Study Start Date : November 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 1: Boosted PI+RAL
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Subjects in this study are HIV-Infected Patients who are on a stable boosted PI regimen; in this group are assigned to switched from their NRTIs as a Backbone to Raltegravir
Drug: Switch NRTIs as a Backbone to Raltegravir
This is a multicenter, pilot randomized, controlled study to evaluate the safety and efficacy of raltegravir in patients switched from a stable boosted PI-based regimen with a NRTI backbone to raltegravir instead of their current NRTIs. A stable boosted PI-based regimen is defined as having a documented HIV RNA <75 copies/mL for ≥ 3 months prior to study entry, while receiving a boosted PI-based with NRTI backbone. Additionally, patients must not have had HIV RNA ≥ 75 copies/mL during the three months prior to study entry. Approximately 25 patients will be enrolled in the raltegravir treatment arm (Group 1) and approximately 25 patients in the continuation of the current NRTI backbone regimen treatment arm (Group 2). Patients will be randomly assigned 1:1 to a treatment group.

No Intervention: 2: Boosted PI+NRTIs
Group 2 Continue the same regimen without change

Primary Outcome Measures :
  1. Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen [ Time Frame: at 24weeks for each patient ]
    Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.

Secondary Outcome Measures :
  1. Virologic Suppression of < 75 Copies/ml at 48 Weeks [ Time Frame: at 48 weeks for each patient ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is a male or female at least 18 years of age on the day of signing the informed consent.
  2. Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR.
  3. Patient has documented HIV RNA <75 copies/mL for at least 3 months prior to study entry while on a stable boosted PI based regimen without a change in antiretroviral therapy and with no documentation of HIV RNA > or = 75 copies/mL during this time.
  4. Patient has no history of documented coronary artery disease that clinical investigator deems as clinically significant.
  5. Patient has the following laboratory values within 35 days prior to the treatment phase of this study:

    • Alkaline phosphatase ≤ 5.0 x upper limit of normal
    • AST (SGOT) and ALT (SGPT) ≤ 5.0 x upper limit of normal. Patients with Hepatitis C Coinfection may be enrolled provided the patients are stable and meet all eligibility criteria.
  6. Patient has no clinical evidence of active pulmonary disease; at the investigators, discretion a chest x-ray could be obtained if felt necessary.
  7. Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study.
  8. Patient agrees to remain off prohibited concomitant medications as outlined in Section 3.2.1 of the protocol.

Exclusion Criteria:

  1. Patients who are currently failing a boosted PI based regimen.
  2. Patient is receiving a second line boosted PI regimen including boosted tripranavir or boosted darunavir.
  3. Patients with chronic hepatitis B infection.
  4. Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
  5. Patient has a history of alcohol or other substance abuse that in the opinion of the investigator would interfere with patient compliance or safety.
  6. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
  7. Patient has ever used any experimental HIV-integrase inhibitor.
  8. Patient has used systemic immunosuppressive therapy (e.g., 20 mg or more of prednisone or equivalent per day) within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
  9. Patient requires hemodialysis.
  10. Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
  11. Patient has chronic hepatitis, including chronic hepatitis B and/or C and has decompensated liver disease.
  12. Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
  13. Subjects who have received investigational medications within 30 days of baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749580

United States, Florida
Hillsborough Health Department Specialty Care Center
Tampa, Florida, United States, 33602
Sponsors and Collaborators
University of South Florida
Merck Sharp & Dohme Corp.
St. Joseph's Hospital, Florida

Additional Information:
Responsible Party: University of South Florida Identifier: NCT00749580     History of Changes
Obsolete Identifiers: NCT00717964
Other Study ID Numbers: Merck-MK0518
First Posted: September 9, 2008    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: December 17, 2014
Last Verified: June 2014

Keywords provided by University of South Florida:

Additional relevant MeSH terms:
Virus 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