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Study of Raltegravir Versus Nucleotide Reverse Transcriptase Inhibitors (NRTIs) as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted Protease Inhibitor (PI) Regimen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:
NCT00717964
First received: July 16, 2008
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

The primary purpose of this research study is to evaluate the safety and tolerability of raltegravir 400 mg taken twice a day compared to an NRTI (nucleotide reverse transcriptase inhibitor) backbone, each with a PI (protease inhibitor) boosted with ritonavir based medication regimen, in HIV-1 positive patients. NRTI and PI are two of the categories of medications currently being used to treat HIV.


Condition Intervention Phase
HIV Infections
 Drug: Raltegravir
Drug: current antiretroviral regimen
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Subjects Switched From a Stable Boosted PI Regimen

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital, Florida:

Primary Outcome Measures:
  • eval safety & toler. of raltegravir vs NRTI, ea w/ PI/r regimen by review of accumulated safety data eval antiretroviral activity of raltegravir ver NRTI backbone, ea w/ PI/r regimen measured by proportion of subjects w/viral load <75 copies/mL. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • eval safety & tolerability of raltegravir vs NRTI ea w/ PI/r regimen, assessed by review of accumulated safety data eval antiretroviral activity of raltegravir ver NRTI ea w/ PI/r regimen measured by proportion of subjects with viral load <75 copies/mL [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: July 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Raltegravir 400 mg BID with current boosted PI regimen
 Drug: Raltegravir
400 mg po BID
Other Name: Isentress
Active Comparator: 2 Drug: current antiretroviral regimen
remain on current antiretroviral regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented HIV RNA <75 copies/mL
  • no history of documented coronary artery disease
  • Subject with Hepatitis C co-infection may be enrolled provided the subjects are stable and meet all eligibility criteria.
  • no clinical evidence of active pulmonary disease
  • agrees to use an acceptable method of birth control throughout the study.

Exclusion Criteria:

  • currently failing a boosted PI based regimen.
  • receiving a second line boosted PI regimen including boosted tipranavir or boosted darunavir.
  • chronic hepatitis B infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717964

Locations
United States, Florida
St Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Investigators
Principal Investigator: Cynthia A Mayer, DO St Joseph's Comprehensive Research Institute
  More Information

No publications provided

Responsible Party: Cynthia A. Mayer, DO, St Joseph's Comprehensive Research Institute
ClinicalTrials.gov Identifier: NCT00717964     History of Changes
Other Study ID Numbers: IIS-CRI-01
Study First Received: July 16, 2008
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital, Florida:
male and female
18 or older years of age
Treatment experienced on stable therapy
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013