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A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen
This study is currently recruiting participants.
Verified by University of South Florida, February 2009
First Received: September 5, 2008   Last Updated: February 19, 2009   History of Changes
Sponsors and Collaborators: University of South Florida
Merck
St. John's Research Institute
Information provided by: University of South Florida
ClinicalTrials.gov Identifier: NCT00749580
  Purpose

The purpose of this study is to evaluate the safety and tolerability of raltegravir 400 mg b.i.d. compared with the NRTI backbone group, each in combination with a boosted PI regimen. Hypothesis: Raltegravir is generally safe and well tolerated compared with NRTIs in combination with a boosted PI regimen.

The purpose is to also evaluate the antiretroviral activity of raltegravir 400 mg b.i.d. versus the NRTI backbone, each in combination with a boosted-PI regimen, as measured by proportion of patients with viral load <75 copies/mL at Week 24.

Hypothesis: The proportion of patients with a viral load <75 copies/mL at Week 24 in the raltegravir 400 mg b.i.d. treatment group is non inferior to that of the NRTI treatment group, each in combination with a boosted PI regimen.


Condition Intervention
Virologic Response
Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen

MedlinePlus related topics: AIDS
Drug Information available for: Raltegravir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • The purpose of this study is to evaluate the safety and tolerability of raltegravir 400 mg b.i.d. compared with the NRTI backbone group, each in combination with a boosted PI regimen, as assessed by a review of the accumulated safety data at Week 24. [ Time Frame: 24 weeks for each patient ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Group 2 Continue the same regimen without change
Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen
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 begin receiving 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 without a change in background antiretroviral therapy and receiving a boosted PI-based regimen, dosed as per standard of care. 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.
2: No Intervention
Group 2 Continue the same regimen without change

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749580

Contacts
Contact: Charurut Somboonwit, MD 8133078015 ext 6460 charurut_somboonwit@doh.stste.fl.us
Contact: Mable Chow 8133078015 ext 6460 mable_chow@doh.state.fl.us

Locations
United States, Florida
Hillsborough Health Depaetment Specialty Care Center Recruiting
Tampa, Florida, United States, 33602
Contact: Mable Chow     813-307-8015 ext 6460     mable_chow@doh.state.fl.us    
Sponsors and Collaborators
University of South Florida
Merck
St. John's Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: USF Health ( Charurut Somboonwit, MD )
Study ID Numbers: Merck-MK0518
Study First Received: September 5, 2008
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00749580     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Safety

Study placed in the following topic categories:
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on May 07, 2009