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 currently recruiting participants.

Verified by St. Joseph's Hospital, Florida, July 2008

Sponsored by:	St. Joseph's Hospital, Florida
Information provided by:	St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:	NCT00717964

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, 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 Subjects Switched From a Stable Boosted PI Regimen

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 Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Raltegravir 400 mg BID with current boosted PI regimen	Drug: Raltegravir 400 mg po BID
2: Active Comparator	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	Recruiting
Tampa, Florida, United States, 33614
Contact: Terry Beitler, RN 813-870-4760 ext 230
Principal Investigator: Cynthia A Mayer, DO

Sponsors and Collaborators

St. Joseph's Hospital, Florida

Investigators

Principal Investigator:

Cynthia A Mayer, DO

St Joseph's Comprehensive Research Institute

More Information

Responsible Party:	St Joseph's Comprehensive Research Institute ( Cynthia A. Mayer, DO )
Study ID Numbers:	IIS-CRI-01
Study First Received:	July 16, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00717964
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009