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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
St. John's Research Institute
Information provided by (Responsible Party):
Charurut Somboonwit, University of South Florida
ClinicalTrials.gov Identifier:
NCT00749580
First received: September 5, 2008
Last updated: November 1, 2011
Last verified: November 2011

September 5, 2008
November 1, 2011
November 2008
July 2011   (final data collection date for primary outcome measure)
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: 48 weeks for each patient ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00749580 on ClinicalTrials.gov Archive Site
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A Pilot,Raltegravir Versus NRTIs as a Backbone Switched From a Stable Boosted PI Regimen
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

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Virologic Response
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.
  • Experimental: 1
    Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen Group 2 Continue the same regimen without change
    Intervention: Drug: Switch NRTIs as a Backbone to Raltegravir in HIV-Infected Patients from a Stable Boosted PI Regimen
  • No Intervention: 2
    Group 2 Continue the same regimen without change
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00749580
Merck-MK0518
No
Charurut Somboonwit, University of South Florida
University of South Florida
  • Merck Sharp & Dohme Corp.
  • St. John's Research Institute
Not Provided
University of South Florida
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP